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
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 Mar 09, 2017
PhotoFix Decellularized Bovine Pericardium
K162506
Cryolife, Inc.
Cardiovascular · 182d
Cleared Oct 14, 2016
VascuCel
K162579
Admedus Regen Pty, Ltd.
Cardiovascular · 29d
Cleared Feb 04, 2016
CorMatrix Tyke
K152127
Cormatrix Cardiovascular, Inc.
Cardiovascular · 188d
Cleared Oct 27, 2015
PremiPatch PTFE Pledget
K151865
Aesculap, Inc.
Cardiovascular · 111d
Cleared Jan 07, 2015
PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch
K142447
Synovis Life Technologies, Inc.
Cardiovascular · 127d
Cleared Nov 25, 2014
VASCU-GUARD Peripheral Vascular Patch
K142461
Synovis Life Technologies, Inc.
Cardiovascular · 84d
Cleared Jul 15, 2014
CORMATRIX ECM FOR VASCULAR REPAIR
K140789
Cormatrix Cardiovascular, Inc.
Cardiovascular · 106d
Cleared Jan 30, 2014
CARDIOCEL
K130872
Celxcel Pty, Ltd.
Cardiovascular · 307d
Cleared Mar 08, 2013
SYNOVIS COLLAGEN MATRIX (TBD)
K122306
Synovis Surgical Innovations
Cardiovascular · 219d
Cleared Dec 07, 2012
SMI CARDIOVASCULAR PATCH
K122105
Solinas Medical, Inc.
Cardiovascular · 143d
Cleared Dec 14, 2011
SMI CARDIOVASCULAR PACH
K112683
Solimas Medical, Inc.
Cardiovascular · 90d
Cleared Jul 26, 2011
PATCH, PLEDGET AND INTRACARDIAC
K111187
Cormatrix Cardiovascular, Inc.
Cardiovascular · 90d
Cleared Sep 20, 2010
ALBOSURE POLYESTER VASCULAR PATCH
K101740
LeMaitre Vascular, Inc.
Cardiovascular · 91d
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 Aug 31, 2005
REGENSIS PERICARDIAL PATCH
K051405
Cormatrix Cardiovascular, Inc.
Cardiovascular · 92d
Cleared Jan 13, 2005
PFA PATCH
K041736
Peritec Biosciences, LLC
Cardiovascular · 199d
Cleared Jul 22, 2004
PTFE FELTS AND PLEDGETS
K041716
Boston Scientific Corp
Cardiovascular · 28d
Cleared Sep 20, 2002
CHASE CARDIOVASCULAR PATCH KIT
K022093
Chase Medical, Inc.
Cardiovascular · 85d
Cleared Jun 03, 2002
CHARE CARIOVASCULAR PATCH
K021129
Chase Medical, Inc.
Cardiovascular · 56d
Cleared Mar 14, 2002
CHASE CARDIOVASCULAR PATCH KIT
K020233
Chase Medical, Inc.
Cardiovascular · 50d
Cleared Feb 26, 2002
CHASE CARDIOVASCULAR PATCH KIT
K020132
Chase Medical, Inc.
Cardiovascular · 42d

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 →