FDA 510(k) Applications for Medical Device Product Code "DRC"
(Trocar)

FDA 510(k) Number Applicant Device Name Decision Date
K895455 ADVANCE MEDICAL DESIGNS, INC. SELDINGER PERCUTANEOUS 2 PC NEEDLES 11/14/1989
K895454 ADVANCE MEDICAL DESIGNS, INC. SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK) 11/14/1989
K911462 APPLIED MEDICAL SURGICAL TROCAR 04/22/1991
K772369 ARGON MEDICAL CORP. NEEDLES USED IN ANGIOGRAPHIC PROCED. 01/24/1978
K924338 ARROW INTL., INC. ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE 03/18/1993
K771261 C.R. BARD, INC. ADVANSET 08/16/1977
K914985 E-Z-EM, INC. DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION 12/20/1991
K890209 E-Z-EM, INC. DISPOSABLE ANGIOGRAPHY NEEDLES 05/19/1989
K940036 ENDOSURG ENDOSURG DISPOSABLE SECONDARY TROCAR 05/12/1994
K840529 EVERMED, INC. STEIGER TUNNELING INSTRUMENT 285 03/12/1984
K951448 GLOBAL MEDICAL PRODUCTS, LTD. GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE 03/27/1996
K111644 Greatbatch Medical MOBICATH TRANSSEPTAL NEEDLE 10/03/2011
K122832 Greatbatch Medical MOBICATH TRANSSEPTAL NEEDLE 12/19/2012
K061070 HANSEN MEDICAL, INC. HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR 10/13/2006
K965051 HEARTPORT, INC. HEARTPORT NEEDLE TROCAR 03/12/1997
K964302 HEARTPORT, INC. HEARTPORT THORACIC TROCAR 05/09/1997
K781221 INSTRUMENTATION LABORATORY CO. DILUTION KIT, THERMAL, COLD PAC 08/23/1978
K853132 J. H. EMERSON CO. EMERSON TRO/CATH TROCAR CATHETERS 01/08/1986
K011373 MEDCANICA, INC. INSTRUMENT DAMPING PORT 10/12/2001
K011349 MEDCANICA, INC. INTERCOSTAL LOCKABLE-DIRECTABLE PORT 10/05/2001
K974743 MEDICAL DEVICE TECHNOLOGIES, INC. MANAN 04/06/1998
K974745 MEDICAL DEVICE TECHNOLOGIES, INC. MANAN GWI GUIDE WIRE INTRODUCER 04/06/1998
K974742 MEDICAL DEVICE TECHNOLOGIES, INC. MANAN POTTS-COURNAND NEEDLE 04/06/1998
K936247 MEDICON INSTRUMENTS, INC. MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES 05/19/1994
K854293 MEDSURG INDUSTRIES, INC. MEDSURG POTT-COURNAND NEEDLE 01/15/1986
K854294 MEDSURG INDUSTRIES, INC. MEDSURG SELDINGER NEEDLE 01/13/1986
K022117 MERIT MEDICAL SYSTEMS, INC. MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 10/11/2002
K871377 NORTH AMERICAN INSTRUMENT CORP. NAMIC COURNAND STYLE INTRODUCER NEEDLE 05/07/1987
K871382 NORTH AMERICAN INSTRUMENT CORP. NAMIC ONE PART INTRODUCER NEEDLE 05/06/1987
K871378 NORTH AMERICAN INSTRUMENT CORP. NAMIC SELDINGER INTRODUCER NEEDLE 05/06/1987
K130843 Oscor Inc. SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE 01/08/2014
K081986 Oscor Inc. SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE 11/14/2008
K172934 Pressure Products Medical Device Manufacturing LLC Needle Free Transseptal Cannula 02/16/2018
K172893 Pressure Products Medical Device Manufacturing LLC SafeSept Needle Free Transseptal Guidewire 12/21/2017
K170671 Pressure Products Medical Device Manufacturing LLC SafeSept Transseptal Guidewire 10/20/2017
K172950 Pressure Products Medical Device Manufacturing LLC TSN Transseptal Needle 02/21/2018
K913267 R-GROUP INTL. R-GROUP INTL. ONE WALL PUNCTURE NEEDLE 06/05/1992
K072278 ST. JUDE MEDICAL BRK TRANSSEPTAL NEEDLE 09/13/2007
K122587 ST. JUDE MEDICAL BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 02/07/2013
K900664 STERIMED, INC. DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES 07/18/1990
K132943 SYNAPTIC MEDICAL LIMITED INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE 08/29/2014
K011727 THOMAS MEDICAL PRODUCTS, INC. TRANSSEPTAL NEEDLE/TROCAR 05/02/2002
K911483 UNITED STATES ENDOSCOPY GROUP, INC. LAPAROSCOPIC TROCAR 07/02/1991
K893707 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT 06/15/1989
K811964 VISITEC CO. VISITEC NEEDLE RANGE (CARDIOVASCULAR) 07/20/1981
K022257 VOMED VOLZER MEDIZINTECHNIK GMBH & CO. VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX 10/04/2002


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