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
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 393d recently vs 134d historically

FDA 510(k) Cleared Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Devices (Product Code DXZ)

90 devices
1–24 of 90
Cleared Apr 18, 2025
PeriBeam® Pericardial Membrane
K240775
Tamabio
Cardiovascular · 393d
Cleared Jul 08, 2020
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
K200955
Vascutek, Ltd.
Cardiovascular · 90d
Cleared Oct 27, 2015
PremiPatch PTFE Pledget
K151865
Aesculap, Inc.
Cardiovascular · 111d
Cleared Oct 23, 2008
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
K082139
Edwards Lifesciences, LLC
Cardiovascular · 86d
Cleared May 12, 2006
IVENA VASCULAR PATCH
K060396
Atrium Medical Corp.
Cardiovascular · 86d
Cleared Jul 22, 2004
PTFE FELTS AND PLEDGETS
K041716
Boston Scientific Corp
Cardiovascular · 28d
Cleared Sep 20, 2001
PRECLUDE PERICARDIAL MEMBRANE
K012098
W.L. Gore & Associates, Inc.
Cardiovascular · 77d
Cleared Nov 07, 2000
ETHIBOND EXCEL VALVE LOOP SUTURE
K003070
Ethicon, Inc.
Cardiovascular · 36d
Cleared Nov 16, 1999
UNI-GRAFT K DV PATCH
K992776
Atrium Medical Corp.
Cardiovascular · 90d
Cleared Apr 08, 1999
ACUSEAL CARDIOVASCULAR PATCH
K984526
W.L. Gore & Associates, Inc.
Cardiovascular · 108d
Cleared Sep 10, 1996
HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH
K962342
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 84d
Cleared Feb 14, 1996
HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC
K955349
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 85d
Cleared Aug 21, 1995
TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET
K953289
Davis & Geck, Inc.
Cardiovascular · 38d
Cleared Aug 21, 1995
POLYETHYLENE TEREPHTHALATE (PET) PLEDGET
K953425
Davis & Geck, Inc.
Cardiovascular · 31d
Cleared Feb 22, 1995
CVPRO CARDIOVASCULAR PATCH
K943736
W.L. Gore & Associates, Inc.
Cardiovascular · 204d
Cleared May 18, 1994
GORE-TEX CARDIOVASCULAR PATCH
K940906
W.L. Gore & Associates, Inc.
Cardiovascular · 83d
Cleared Oct 22, 1993
GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE
K930950
W.L. Gore & Associates, Inc.
Cardiovascular · 241d
Cleared May 27, 1993
HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC
K931386
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 70d
Cleared Nov 05, 1991
GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE
K914448
W.L. Gore & Associates, Inc.
Cardiovascular · 32d
Cleared Nov 05, 1991
GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE
K914450
W.L. Gore & Associates, Inc.
Cardiovascular · 32d
Cleared Oct 11, 1991
GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM
K912107
W.L. Gore & Associates, Inc.
Cardiovascular · 151d
Cleared Mar 26, 1991
GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE
K910464
W.L. Gore & Associates, Inc.
Cardiovascular · 50d
Cleared Mar 11, 1991
WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS
K905496
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 94d
Cleared Nov 01, 1984
PERICARDIAL PATCH
K833763
American Edwards Laboratories
Cardiovascular · 372d

About Product Code DXZ - Regulatory Context

510(k) Submission Activity

90 total 510(k) submissions under product code DXZ since 1977, with 90 receiving FDA clearance (average review time: 137 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DXZ Product Code

Recent submissions under DXZ have taken an average of 393 days to reach a decision - up from 134 days historically. Manufacturers should account for longer review timelines in current project planning.

DXZ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →