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., Meadox Medicals, Div. Boston Scientific Corp. and Ethicon, Inc..

90
Total
90
Cleared
137d
Avg days
1977
Since
90 devices
25–48 of 90
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 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 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 Jan 05, 1977
FELT, SURGICAL DACRON
K760516
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 133d