FDA 510(k) Applications for Medical Device Product Code "BSY"
(Catheters, Suction, Tracheobronchial)

FDA 510(k) Number Applicant Device Name Decision Date
K822398 ACKRAD LABORATORIES ACKRAD BRONCHITRAC 10/04/1982
K854320 ACKRAD LABORATORIES ACKRAD ORAL SUCTION TUBE 01/10/1986
K833633 ACKRAD LABORATORIES BRONCHITRAC DF DUAL RESP/CATHETER 12/08/1983
K850784 ACKRAD LABORATORIES BRONCHITRAC L 03/25/1985
K960488 ALCOVE MEDICAL, INC. NEO 2 LINE SUCTION SYSTEM 04/26/1996
K992902 AMBU, INC. AMBU HAND POWER SUCTION PUMP 10/25/1999
K873610 AMERICAN OMNI MEDICAL, INC. PEDIATRIC BUBBLE TRAP CAT. NO. B-100 11/05/1987
K842198 AMERICAN PHARMASEAL DIV. AHSC AMER. PHARMASEAL NO TOUCH SATIN CATHET 06/25/1984
K872917 AMERICAN PHARMASEAL DIV. AHSC JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER 08/11/1987
K820369 AMERICAN PHARMASEAL DIV. AHSC SUCTION CATHETERS & KITS 04/16/1982
K840664 AMERICAN PHARMASEAL DIV. AHSC TRACHEOSTOMY CLEANING TRAY 03/12/1984
K902093 AMG MEDICAL EQUIPMENTS, INC. RESU-GARD CATHETER SUCTION 10/23/1990
K973199 AMSINO INTL., INC. AMSINO SUCTION CATHETER 09/10/1997
K893462 ATHEUS CORP. NU-TRAP SUCTION CATHETER W/MUCUS TRAP 06/08/1989
K872283 BALLARD MEDICAL PRODUCTS ORAL SUCTION CATHETER 08/03/1987
K873810 BALLARD MEDICAL PRODUCTS SAFETY SHIELD SUCTION CATHETER 12/11/1987
K872621 BALLARD MEDICAL PRODUCTS TRACH CARE CATHETER 09/15/1987
K964369 BALLARD MEDICAL PRODUCTS TRACH CARE SET WITH MICROBAN 02/11/1997
K873732 BALLARD MEDICAL PRODUCTS TRACH CARE START KIT 10/13/1987
K810023 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC HYDROPHILIC COATED CATHETER 02/06/1981
K921851 BOSTON PACIFIC MEDICAL, INC. 4 SURE TM SUCTION CATHETERS & KITS 07/07/1993
K902297 BUSSE HOSPITAL DISPOSABLES, INC. BUSSE BAC/SHIELD 08/17/1990
K875058 BUSSE HOSPITAL DISPOSABLES, INC. STERILE MUCUS SPECIMEN TRAP, MODELS 406 & 407 02/12/1988
K801814 CONCORD LABORATORIES, INC. CATHETER SUCTION TRACHEOBRONCHIAL 08/14/1980
K871825 CONCORD LABORATORIES, INC. MECONIUM SUCTION CATHETER 06/29/1987
K864535 CONCORD LABORATORIES, INC. TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110 01/06/1987
K903552 CONCORD PROTEX ORAL-CATH SUCTION CATHETER 01/02/1991
K902383 CONCORD/PORTEX STERI-CATH(TM) 07/12/1990
K902687 CONCORD/PORTEX STERI-CATH-DL 08/29/1990
K892343 CONCORD/PORTEX SUCTION CONTROL VALVE 04/24/1989
K791253 CONPHAR, INC. CONPHAR SUCTION CATHETER-W/0 CONTROL 07/30/1979
K952396 CONTOUR FABRICATORS OF FLORIDA, INC. REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION 08/15/1995
K952395 CONTOUR FABRICATORS OF FLORIDA, INC. REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION 08/15/1995
K910239 DEY LABORATORIES, INC. NEBU-SOL METERED DOSE DISPENSER (TM) 05/22/1991
K760371 DRYDEN CORP. VENT-O2-CATH 08/13/1976
K922843 DYNAREX CORP. DYNAREX SUCTION CATHETERS & KITS 01/11/1993
K842779 EDWARD MANOUGIAN, M.D. ACT, SUCTION TIP 10/12/1984
K822724 EXCO, INC. SUCTION TUBES 10/13/1982
K903669 GENERAL MEDICAL CO. GENESIS INSUFFLATING CATHETER 09/12/1990
K870962 GESCO INTL., INC. GESCO ASPIRATOR 05/22/1987
K862132 HOSPITAL CONCEPTS, INC. HCI MECONIUM ASPIRATOR 06/19/1986
K955645 HUDSON RESPIRATORY CARE, INC. CATH-GUIDE 03/12/1996
K813209 HYDROMER, INC. TRACHEOBRONCHIAL SUCTION CATHETER 12/09/1981
K842166 INTERMED, INC. INTERMED, INS STERILE WATER/SALINE 02/12/1985
K871407 INTERTECH RESOURCES, INC. MECONIUM ASPIRATOR 06/15/1987
K893204 ISLAND MEDICAL MUC-X 06/01/1989
K833375 JINOTTI ENT INC. MEDICAL DUAL PURPOSE CATHETER 02/10/1984
K944251 KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH KENDALL MODU-VAC CLOSED SUCTION SYSTEM 09/21/1994
K885131 KIT PAK, INC. KIT PAK SUCTION CATHETER KIT 01/09/1989
K850105 KM PRODUCTS KM PRODUCTS ASPIRATING TUBING 03/21/1985
K883384 M.D. ENGINEERING, INC. TS1000 SUCTION TIP 11/02/1988
K031997 MALLINCKRODT DAR S.R.L. MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM 11/25/2003
K972258 MALLINCKRODT MEDICAL HI-CARE CLOSED SUCTION SYSTEM 12/29/1997
K800503 MEDI-CRAFT LTD. SUCTION CATHETER 03/18/1980
K861949 MEDI-CRAFT LTD. SUCTION CATHETER KIT 10/22/1986
K842205 MEDI-TECH, INC. OXY-VAC 06/25/1984
K871949 MEDICAL TECHNOLOGIES OF GEORGIA MMG DELEE SUCTION CATHETER W/MUCOUS TRAP 06/15/1987
K811542 MGN MEDICAL MANUFACTURING, INC. MGN SUCTION CATHETER 06/18/1981
K862181 MICHAEL REESE HOSPITAL AND MEDICAL CENTER MECONIUM SUCTION TRAP 08/13/1986
K890425 NEOTECH PRODUCTS, INC. NEOTECH MUCUS TRAP W/CATHETER 04/19/1989
K981910 NI-MED, INC. SUCTION CATHETER 08/24/1998
K813163 NORTHERN MEDICAL INDUSTRIES SUCTION CATHETER 12/29/1981
K902814 ORION LIFE SYSTEMS, INC. SUCTION CATHETER, STERILE 08/17/1990
K896887 ORION LIFE SYSTEMS, INC. TRACHAEL SUCTION SET 04/23/1990
K912596 PACIFIC DEVICE, INC. MECONIUM ASPIRATION 07/30/1991
K843797 PACO PHARMACEUTICAL SERVICES, INC. STERILE SALINE SOLUTION 01/18/1985
K850032 PACO RESEARCH CORP. A FAMILY OF TRACHEOBRONCHIAL SUCTION CATHETER PROD 02/01/1985
K850864 PACO RESEARCH CORP. TRACHEOBRONCHIAL SUCTION KITS W/CATHETERS ETO 05/02/1985
K852079 PENNINE MEDICAL LTD. PENNINE DERBY YANKAUER 06/03/1985
K852080 PENNINE MEDICAL LTD. PENNINE SUCTION CATHETERS 06/03/1985
K833908 PORTEX, INC. IRRI-CATH 02/04/1984
K953226 PREMIUM PLASTICS, INC. PULM O2 SUCTION CATHETER TRAYS 08/08/1995
K881428 PULMONARY MEDICAL DEVICES, INC. OXY-CATH 06/10/1988
K935553 PURITAS HEALTH CARE, INC. MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP 01/14/1994
K935583 PURITAS HEALTH CARE, INC. SUCTION SET, TRACHAEL 04/11/1994
K935600 PURITAS HEALTH CARE, INC. TRACHEAL SUCTION CATHETER 05/10/1994
K894299 REPRO-MED SYSTEMS, INC. REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM 09/22/1989
K892529 REPRO-MED SYSTEMS, INC. REPRO-MED NEONATE ASPIRATION SYSTEM 06/12/1989
K841425 RESEARCH MEDICAL, INC. JINOTTI OXYGEN/SUCTION CATHETER 09/13/1984
K882017 RESPIRONICS, INC. RESPIRONICS SUCTIONEASY 07/14/1988
K860802 SHERIDAN CATHETER CORP. TRACHEOBRONCHIAL SUCTION CATHETER 04/02/1986
K864468 SHERIDAN CATHETER CORP. TRACHEOBRONCHIAL SUCTION CATHETER 01/06/1987
K922148 SHERWOOD MEDICAL CO. ARGYLE AERO-JET SUCTION CATHETER 12/07/1992
K925556 SHERWOOD MEDICAL CO. ARGYLE ASPIR-FLEX SUCTION CATHETER 07/30/1993
K934723 SHERWOOD MEDICAL CO. ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM 11/30/1993
K955831 SHERWOOD MEDICAL CO. ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM 03/28/1996
K801551 SHERWOOD MEDICAL CO. ARGYLE SAF-T-MARK SUCTION CATHETER 07/21/1980
K812747 SHERWOOD MEDICAL CO. ARGYLE SUCTION CATHETERS 10/23/1981
K830709 SHERWOOD MEDICAL CO. ARGYLE SUCTION CATHETERS 03/29/1983
K790606 SNYDER LABORATORIES, INC. CATHETERS, GREENLINE SUCTION 04/23/1979
K811241 SONTEK INDUSTRIES, INC. BODAI SUCTION -SAFE 4 05/27/1981
K813324 SONTEK INDUSTRIES, INC. BODAI SWIVEL Y 12/29/1981
K961707 SORENSON CRITICAL CARE TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM 03/11/1997
K903740 SOREX MEDICAL TRACH-EZE 12/06/1990
K982945 SPIRIT MEDICAL SYSTEMS, INC. DUAL PURPOSE CLOSED CATHETER 09/22/1998
K896321 SUPERIOR HEALTHCARE GROUP, INC. NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. 11/13/1989
K841480 SUPERIOR PLASTIC PRODUCTS CORP. INFECTION CONTROL VALVE 04/25/1984
K892441 THE KENDAL CO. KENDALL CURITY SUCTION CATHETERS 05/31/1989
K820109 TRAVENOL LABORATORIES, S.A. RADIATION STERILIZED SUCTION CATHETERS 01/29/1982
K843076 TRAVENOL LABORATORIES, S.A. SUCTION CATHETER KIT 11/20/1984
K872141 TRI-STATE HOSPITAL SUPPLY CORP. CENTURION SPECIMEN TRAP W/CATHETER 08/26/1987
K923098 TRINITY LABORATORIES, INC. STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE 09/21/1992
K951506 TRINITY LABORATORIES, INC. SUCTION CATHETER KIT, STERILE, SINGLE-USE 07/03/1995
K884944 TULAN CORP. C/O RICHARD HAMER ASSOC. TU SUCTIONTRAP 02/03/1989
K903480 UN-I-MED, INC. HANN-VAC TM, DISPOSABLE,SUCTION CATHETER 10/01/1991
K945994 UNIVERSAL MEDICAL PRODUCTS, INC. DUAL PURPOSE CATHETER 06/21/1995
K896730 UNOPLAST A/S SUCTION CATHETER STRAIGHT/COUDE 03/30/1990
K951745 VITAL SIGNS, INC. CONNECTING TUBE 05/30/1995
K945950 VITAL SIGNS, INC. TRIGUARD(TM) SUCTION SYSTEM 12/27/1994
K910909 VYGON CORP. MUCAID 05/20/1991
K910908 VYGON CORP. MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING 05/20/1991
K851473 VYGON CORP. VYGON DELEE SUCTION CATHETER CODE NO 533 07/15/1985
K863497 WELMED SYSTEMS, INC. SUCTION CATHETER KIT 10/06/1986
K896560 WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) MUCOUS TRAP 01/22/1990
K896797 WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) SUCTION CATHETER KIT 02/16/1990
K760427 WILL ROSS CO. CATHETER, DOVER SUCTION W/ GLOVE 09/09/1976


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