DXZ · Class II · 21 CFR 870.3470

FDA Product Code DXZ: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Leading manufacturers include W.L. Gore & Associates, Inc., Chase Medical, Inc. and Meadox Medicals, Div. Boston Scientific Corp..

90
Total
90
Cleared
137d
Avg days
1977
Since
90 devices
73–90 of 90
Cleared May 25, 1988
OCHSNER & MICRON FABRIC PATCH
K881508
Intervascular, Inc.
Cardiovascular · 44d
Cleared Dec 30, 1985
PERI-GUARD PERICARDIAL PATCH
K842066
Genetic Laboratories, Inc.
Cardiovascular · 616d
Cleared Nov 01, 1984
PERICARDIAL PATCH
K833763
American Edwards Laboratories
Cardiovascular · 372d
Cleared May 30, 1984
HANCOCK PERICARDIAL PATCH
K840262
Extracorporeal Medical Specialities, Inc.
Cardiovascular · 132d
Cleared Jan 06, 1984
GORE-TEX SURGICAL MEMBRANE
K831516
W.L. Gore & Associates, Inc.
Cardiovascular · 302d
Cleared Dec 26, 1983
PERI-GUARD PERICARDIAL PATCH-HERNIA
K833021
Genetic
Cardiovascular · 111d
Cleared Aug 31, 1983
HANCOCK PERICARDIAL PATCH
K830863
Extracorporeal Medical Specialities, Inc.
Cardiovascular · 166d
Cleared Aug 13, 1983
VASCULAR GRAFT/BIFURCATED/FEP-RINGED
K830806
W.L. Gore & Associates, Inc.
Cardiovascular · 152d
Cleared Mar 10, 1983
PATCH
K823345
Shiley, Inc.
Cardiovascular · 122d
Cleared Jan 12, 1983
GORE-TES EXPANDED PTFE PATCH
K821717
W.L. Gore & Associates, Inc.
Cardiovascular · 216d
Cleared Aug 19, 1982
PERIGUARD PERICARDIAL PATCH
K821532
Genetic Laboratories, Inc.
Cardiovascular · 87d
Cleared Sep 16, 1981
GORE-TEX CARDIOVASCULAR PATCH
K811841
W.L. Gore & Associates, Inc.
Cardiovascular · 77d
Cleared Aug 31, 1981
DACRON PLEDGET SUTURE BUTTRESS
K812254
Ethicon, Inc.
Cardiovascular · 19d
Cleared Aug 12, 1981
TEFLON PLEDGET SUTURE BUTTRESS
K811872
Ethicon, Inc.
Cardiovascular · 42d
Cleared Aug 13, 1980
IONESCU-SHILEY PERICARDIAL PATCH
K801764
Shiley, Inc.
Cardiovascular · 16d
Cleared Dec 07, 1979
SCI MED PERICARDIAL SUBSTITUTE
K791792
Scimed Life Systems, Inc.
Cardiovascular · 85d
Cleared Oct 05, 1977
PATCH FABRIC
K770835
Usci, Div. C.R. Bard, Inc.
Cardiovascular · 152d
Cleared Jan 05, 1977
FELT, SURGICAL DACRON
K760516
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 133d