FDA 510(k) Applications for Medical Device Product Code "DWP"
(Dilator, Vessel, Surgical)

FDA 510(k) Number Applicant Device Name Decision Date
K832595 ABBOTT LABORATORIES VESSEL DILATOR 08/31/1983
K810894 AMERICAN EDWARDS LABORATORIES FOGARTY FLEXIBLE CALIBRATOR 05/15/1981
K812935 AMERICAN EDWARDS LABORATORIES FOGARTY FLEXIBLE PROBE 11/16/1981
K822687 AMERICAN EDWARDS LABORATORIES REUSABLE FOGARTY FLEXIBLE CALIBRATOR 10/04/1982
K902143 BAXTER HEALTHCARE CORP. FOGARTY VESSEL CALIBRATOR 10/16/1990
K905159 BIO-VASCULAR, INC. FLO-RESTER(R) VESSEL SIZER 02/07/1991
K910682 BIO-VASCULAR, INC. ROBICSEK PROBE/RETRACTOR 05/08/1991
K833676 CIMED INTL., INC. SURGICAL VESSEL DILATORS-CATHERIZA- 03/19/1984
K163524 Fetzer Medical GmbH & Co. KG Vessel Dilator 06/29/2017
K030788 GEISTER MEDIZINTECHNIK GMBH KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS 07/12/2003
K100518 INSTRUMED INTERNATIONAL, INC. INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 08/31/2010
K891786 PIONEERING TECHNOLOGIES, INC. PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) 10/12/1989
K960312 R D INTL. RDI CARDIAC INSULATION PAD 04/19/1996
K792134 SHILEY, INC. BONCHEK-SHILEY VEIN DISTENTION SYSTEM 12/04/1979
K790938 SHILEY, INC. SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO 06/13/1979
K130896 SYNOVIS LIFE TECHNOLOGIES, INC. VASCULAR PROBE, VASCULAR PROBE ES 04/24/2013
K911475 UNITED STATES ENDOSCOPY GROUP, INC. LAPAROSCOPIC VESSEL ARTICULATOR 07/02/1991
K912548 VASCUTECH, INC. LEMAITRE-BOOKWALTER VESSEL DEVICES 09/18/1991


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