Panels › Cardiovascular › Product code DXZ · Class 2
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Regulation 870.3470
0510(k)s in 12 months (90 all time)
3recalls in 12 months (21 all time)
20recalls that name a 510(k)
Top companies in DXZ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 24, 1997 | K973178 | FLUORO-TEX SURGICAL MEMBRANE Bridger Biomed, Inc. | DXZ |
| Oct 31, 1997 | K963967 | GLYCAR PERICARDIAL PATCH Glycar, Inc. | DXZ |
| Oct 31, 1997 | K963368 | GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE Glycar, Inc. | DXZ |
| Sep 23, 1997 | K964467 | SHELHIGH PERICARDIAL PATCH Shelhigh, Inc. | DXZ |
| Nov 21, 1996 | K963611 | VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH Vascutek, Ltd. | DXZ |
| Sep 10, 1996 | K962342 | HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH Meadox Medicals, Div. Boston Scientific Corp. | DXZ |
| Feb 14, 1996 | K955349 | HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC Meadox Medicals, Div. Boston Scientific Corp. | DXZ |
| Aug 21, 1995 | K953425 | POLYETHYLENE TEREPHTHALATE (PET) PLEDGET Davis & Geck, Inc. | DXZ |
| Aug 21, 1995 | K953289 | TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET Davis & Geck, Inc. | DXZ |
| Feb 22, 1995 | K943736 | CVPRO CARDIOVASCULAR PATCH W. L. Gore & Associates, Inc. | DXZ |
| Jul 7, 1994 | K942010 | VASCU-GUARD Bio-Vascular, Inc. | DXZ |
| May 18, 1994 | K940906 | GORE-TEX CARDIOVASCULAR PATCH W. L. Gore & Associates, Inc. | DXZ |
| Oct 22, 1993 | K930950 | GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE W. L. Gore & Associates, Inc. | DXZ |
| May 27, 1993 | K931386 | HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC Meadox Medicals, Div. Boston Scientific Corp. | DXZ |
| Nov 25, 1992 | K921659 | ULTRA LOW POROSITY DACRON WOVEN PATCH Intervascular, Inc. | DXZ |
| Nov 4, 1992 | K921895 | TISSUE PATCH, TISSUE GRAFT Bio-Vascular, Inc. | DXZ |
| Dec 20, 1991 | K905073 | CARDIOVASCULAR REPAIR PATCH Impra, Inc. | DXZ |
| Nov 5, 1991 | K914450 | GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE W. L. Gore & Associates, Inc. | DXZ |
| Nov 5, 1991 | K914448 | GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE W. L. Gore & Associates, Inc. | DXZ |
| Oct 11, 1991 | K912107 | GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM W. L. Gore & Associates, Inc. | DXZ |
| Mar 26, 1991 | K910464 | GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE W. L. Gore & Associates, Inc. | DXZ |
| Mar 11, 1991 | K905496 | WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS Meadox Medicals, Div. Boston Scientific Corp. | DXZ |
| May 25, 1988 | K881508 | OCHSNER & MICRON FABRIC PATCH Intervascular, Inc. | DXZ |
| Dec 30, 1985 | K842066 | PERI-GUARD PERICARDIAL PATCH Genetic Laboratories, Inc. | DXZ |
| Nov 1, 1984 | K833763 | PERICARDIAL PATCH American Edwards Laboratories | DXZ |
| May 30, 1984 | K840262 | HANCOCK PERICARDIAL PATCH Extracorporeal Medical Specialities, Inc. | DXZ |
| Jan 6, 1984 | K831516 | GORE-TEX SURGICAL MEMBRANE W. L. Gore & Associates, Inc. | DXZ |
| Dec 26, 1983 | K833021 | PERI-GUARD PERICARDIAL PATCH-HERNIA Genetic | DXZ |
| Aug 31, 1983 | K830863 | HANCOCK PERICARDIAL PATCH Extracorporeal Medical Specialities, Inc. | DXZ |
| Aug 13, 1983 | K830806 | VASCULAR GRAFT/BIFURCATED/FEP-RINGED W. L. Gore & Associates, Inc. | DXZ |
| Mar 10, 1983 | K823345 | PATCH Shiley, Inc. | DXZ |
| Jan 12, 1983 | K821717 | GORE-TES EXPANDED PTFE PATCH W. L. Gore & Associates, Inc. | DXZ |
| Aug 19, 1982 | K821532 | PERIGUARD PERICARDIAL PATCH Genetic Laboratories, Inc. | DXZ |
| Sep 16, 1981 | K811841 | GORE-TEX CARDIOVASCULAR PATCH W. L. Gore & Associates, Inc. | DXZ |
| Aug 31, 1981 | K812254 | DACRON PLEDGET SUTURE BUTTRESS ETHICON, Inc. | DXZ |
| Aug 12, 1981 | K811872 | TEFLON PLEDGET SUTURE BUTTRESS ETHICON, Inc. | DXZ |
| Aug 13, 1980 | K801764 | IONESCU-SHILEY PERICARDIAL PATCH Shiley, Inc. | DXZ |
| Dec 7, 1979 | K791792 | SCI MED PERICARDIAL SUBSTITUTE Scimed Life Systems, Inc. | DXZ |
| Oct 5, 1977 | K770835 | PATCH FABRIC Usci, Div. C.R. Bard, Inc. | DXZ |
| Jan 5, 1977 | K760516 | FELT, SURGICAL DACRON Meadox Medicals, Div. Boston Scientific Corp. | DXZ |
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