Product Code: DXZ FDA class 2 21 CFR 870.3470

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Cardiovascular

The Intracardiac Patch and Pledget made from polyethylene terephthalate (PETP), polytetrafluoroethylene (PTFE), or polypropylene is a cardiovascular implant used to repair septal defects, reinforce suture lines, or reconstruct cardiac structures during open-heart surgery. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DXZ and the applicable regulation is 21 CFR 870.3470, under the Cardiovascular medical specialty. This device is an implant.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DXZ
Device Class: FDA class 2
Regulation Number: 870.3470
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 90 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240775	PeriBeam® Pericardial Membrane	Apr 18, 2025	Substantially Equivalent	Tamabio
K200955	Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch	Jul 08, 2020	Substantially Equivalent	Vascutek, Ltd.
K162506	PhotoFix Decellularized Bovine Pericardium	Mar 09, 2017	Substantially Equivalent	Cryolife, Inc.
K162579	VascuCel	Oct 14, 2016	Substantially Equivalent	Admedus Regen Pty, Ltd.
K152127	CorMatrix Tyke	Feb 04, 2016	Substantially Equivalent	Cormatrix Cardiovascular, Inc.
K151865	PremiPatch PTFE Pledget	Oct 27, 2015	Substantially Equivalent	Aesculap, Inc.
K142447	PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch	Jan 07, 2015	Substantially Equivalent	Synovis Life Technologies, Inc.
K142461	VASCU-GUARD Peripheral Vascular Patch	Nov 25, 2014	Substantially Equivalent	Synovis Life Technologies, Inc.
K140789	CORMATRIX ECM FOR VASCULAR REPAIR	Jul 15, 2014	Substantially Equivalent	Cormatrix Cardiovascular, Inc.
K130872	CARDIOCEL	Jan 30, 2014	Substantially Equivalent	Celxcel Pty, Ltd.
K122306	SYNOVIS COLLAGEN MATRIX (TBD)	Mar 08, 2013	Substantially Equivalent	Synovis Surgical Innovations
K122105	SMI CARDIOVASCULAR PATCH	Dec 07, 2012	Substantially Equivalent	Solinas Medical, Inc.
K112683	SMI CARDIOVASCULAR PACH	Dec 14, 2011	Substantially Equivalent	Solimas Medical, Inc.
K111187	PATCH, PLEDGET AND INTRACARDIAC	Jul 26, 2011	Substantially Equivalent	Cormatrix Cardiovascular, Inc.
K101740	ALBOSURE POLYESTER VASCULAR PATCH	Sep 20, 2010	Substantially Equivalent	LeMaitre Vascular, Inc.
K101866	CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH	Jul 23, 2010	Substantially Equivalent	Cryolife, Inc.
K090637	CARDIO-WRAP	Jan 07, 2010	Unknown	Mast Biosurgery USA, Inc.
K091626	CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH	Aug 07, 2009	Substantially Equivalent	Cryolife, Inc.
K082139	EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700	Oct 23, 2008	Substantially Equivalent	Edwards Lifesciences, LLC
K081438	MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT	Oct 17, 2008	Substantially Equivalent	Lifenet Health
K063349	CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR	Feb 16, 2007	Substantially Equivalent	Cormatrix Cardiovascular, Inc.
K060396	IVENA VASCULAR PATCH	May 12, 2006	Substantially Equivalent	Atrium Medical Corp.
K052416	PERIPRO PATCH	Oct 25, 2005	Substantially Equivalent	Hancock/Jaffe Laboratories
K051405	REGENSIS PERICARDIAL PATCH	Aug 31, 2005	Substantially Equivalent	Cormatrix Cardiovascular, Inc.
K041736	PFA PATCH	Jan 13, 2005	Substantially Equivalent	Peritec Biosciences, LLC
K041716	PTFE FELTS AND PLEDGETS	Jul 22, 2004	Substantially Equivalent	Boston Scientific Corp
K040415	PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT	Apr 14, 2004	Substantially Equivalent	Synovis Surgical Innovations
K040162	CORRESTORE PATCH SYSTEM	Mar 16, 2004	Substantially Equivalent	Somanetics Corp.
K031948	PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16	Sep 16, 2003	Substantially Equivalent	Pm Devices, Inc.
K031586	CORRESTORE PATCH SYSTEM	Aug 07, 2003	Substantially Equivalent	Somanetics Corp.
K022093	CHASE CARDIOVASCULAR PATCH KIT	Sep 20, 2002	Substantially Equivalent	Chase Medical, Inc.
K021129	CHARE CARIOVASCULAR PATCH	Jun 03, 2002	Substantially Equivalent	Chase Medical, Inc.
K020233	CHASE CARDIOVASCULAR PATCH KIT	Mar 14, 2002	Substantially Equivalent	Chase Medical, Inc.
K020132	CHASE CARDIOVASCULAR PATCH KIT	Feb 26, 2002	Substantially Equivalent	Chase Medical, Inc.
K011487	CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS	Nov 21, 2001	Substantially Equivalent	Somanetics Corp.
K012098	PRECLUDE PERICARDIAL MEMBRANE	Sep 20, 2001	Substantially Equivalent	W. L. Gore & Associates, Inc.
K012248	CHASE CARDIOVASCULAR PATCH	Aug 10, 2001	Substantially Equivalent	Chase Medical, Inc.
K003467	CHASE CARDIOVASCULAR PATCH	Jan 29, 2001	Substantially Equivalent	Chase Medical, Inc.
K001785	SURGISIS PERIPHERAL VASCULAR PATCH	Dec 27, 2000	Substantially Equivalent	Cook Biotech, Inc.
K003070	ETHIBOND EXCEL VALVE LOOP SUTURE	Nov 07, 2000	Substantially Equivalent	ETHICON, Inc.
K001662	CHASE CARDIOVASCULAR PATCH	Aug 02, 2000	Substantially Equivalent	Chase Medical, Inc.
K994032	FLUORO-TEX CARDIOVASCULAR PATCH	Jul 07, 2000	Substantially Equivalent	Bridger Biomed, Inc.
K993288	SULZER CARBOMEDICS CARDIOFIX PERICARDIUM	Dec 29, 1999	Substantially Equivalent	Sulzer Carbomedics, Inc.
K992776	UNI-GRAFT K DV PATCH	Nov 16, 1999	Substantially Equivalent	Atrium Medical Corp.
K984526	ACUSEAL CARDIOVASCULAR PATCH	Apr 08, 1999	Substantially Equivalent	W. L. Gore & Associates, Inc.
K983602	CV PERI-GUARD AND VASCU-GUARD	Nov 12, 1998	Substantially Equivalent	Bio-Vascular, Inc.
K982810	SHELHIGH NO-REACT VASCUPATCH	Oct 28, 1998	Substantially Equivalent	Shelhigh, Inc.
K974914	SHELHIGH NO-REACT PERICARDIAL PATCHES	Jun 03, 1998	Substantially Equivalent	Shelhigh, Inc.
K972201	PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE	Apr 14, 1998	Substantially Equivalent	Sulzer Carbomedics, Inc.
K971726	CV PERI-GUARD - CARDIOVASCULAR PATCH	Apr 10, 1998	Substantially Equivalent	Bio-Vascular, Inc.
K973178	FLUORO-TEX SURGICAL MEMBRANE	Nov 24, 1997	Substantially Equivalent	Bridger Biomed, Inc.
K963967	GLYCAR PERICARDIAL PATCH	Oct 31, 1997	Substantially Equivalent	Glycar, Inc.
K963368	GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE	Oct 31, 1997	Substantially Equivalent	Glycar, Inc.
K964467	SHELHIGH PERICARDIAL PATCH	Sep 23, 1997	Substantially Equivalent	Shelhigh, Inc.
K963611	VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH	Nov 21, 1996	Substantially Equivalent	Vascutek, Ltd.
K962342	HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH	Sep 10, 1996	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K955349	HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC	Feb 14, 1996	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K953425	POLYETHYLENE TEREPHTHALATE (PET) PLEDGET	Aug 21, 1995	Substantially Equivalent	Davis & Geck, Inc.
K953289	TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET	Aug 21, 1995	Substantially Equivalent	Davis & Geck, Inc.
K943736	CVPRO CARDIOVASCULAR PATCH	Feb 22, 1995	Substantially Equivalent	W. L. Gore & Associates, Inc.
K942010	VASCU-GUARD	Jul 07, 1994	Substantially Equivalent	Bio-Vascular, Inc.
K940906	GORE-TEX CARDIOVASCULAR PATCH	May 18, 1994	Substantially Equivalent	W. L. Gore & Associates, Inc.
K930950	GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE	Oct 22, 1993	Substantially Equivalent	W. L. Gore & Associates, Inc.
K931386	HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC	May 27, 1993	Unknown	Meadox Medicals, Div. Boston Scientific Corp.
K921659	ULTRA LOW POROSITY DACRON WOVEN PATCH	Nov 25, 1992	Unknown	Intervascular, Inc.
K921895	TISSUE PATCH, TISSUE GRAFT	Nov 04, 1992	Unknown	Bio-Vascular, Inc.
K905073	CARDIOVASCULAR REPAIR PATCH	Dec 20, 1991	Substantially Equivalent	Impra, Inc.
K914450	GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE	Nov 05, 1991	Substantially Equivalent	W. L. Gore & Associates, Inc.
K914448	GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE	Nov 05, 1991	Substantially Equivalent	W. L. Gore & Associates, Inc.
K912107	GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM	Oct 11, 1991	Substantially Equivalent	W. L. Gore & Associates, Inc.
K910464	GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE	Mar 26, 1991	Substantially Equivalent	W. L. Gore & Associates, Inc.
K905496	WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS	Mar 11, 1991	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K881508	OCHSNER & MICRON FABRIC PATCH	May 25, 1988	Substantially Equivalent	Intervascular, Inc.
K842066	PERI-GUARD PERICARDIAL PATCH	Dec 30, 1985	Substantially Equivalent	Genetic Laboratories, Inc.
K833763	PERICARDIAL PATCH	Nov 01, 1984	Substantially Equivalent	American Edwards Laboratories
K840262	HANCOCK PERICARDIAL PATCH	May 30, 1984	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K831516	GORE-TEX SURGICAL MEMBRANE	Jan 06, 1984	Substantially Equivalent	W. L. Gore & Associates, Inc.
K833021	PERI-GUARD PERICARDIAL PATCH-HERNIA	Dec 26, 1983	Substantially Equivalent	Genetic
K830863	HANCOCK PERICARDIAL PATCH	Aug 31, 1983	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K830806	VASCULAR GRAFT/BIFURCATED/FEP-RINGED	Aug 13, 1983	Substantially Equivalent	W. L. Gore & Associates, Inc.
K823345	PATCH	Mar 10, 1983	Substantially Equivalent	Shiley, Inc.
K821717	GORE-TES EXPANDED PTFE PATCH	Jan 12, 1983	Substantially Equivalent	W. L. Gore & Associates, Inc.
K821532	PERIGUARD PERICARDIAL PATCH	Aug 19, 1982	Substantially Equivalent	Genetic Laboratories, Inc.
K811841	GORE-TEX CARDIOVASCULAR PATCH	Sep 16, 1981	Substantially Equivalent	W. L. Gore & Associates, Inc.
K812254	DACRON PLEDGET SUTURE BUTTRESS	Aug 31, 1981	Substantially Equivalent	ETHICON, Inc.
K811872	TEFLON PLEDGET SUTURE BUTTRESS	Aug 12, 1981	Substantially Equivalent	ETHICON, Inc.
K801764	IONESCU-SHILEY PERICARDIAL PATCH	Aug 13, 1980	Substantially Equivalent	Shiley, Inc.
K791792	SCI MED PERICARDIAL SUBSTITUTE	Dec 07, 1979	Substantially Equivalent	Scimed Life Systems, Inc.
K770835	PATCH FABRIC	Oct 05, 1977	Substantially Equivalent	Usci, Div. C.R. Bard, Inc.
K760516	FELT, SURGICAL DACRON	Jan 05, 1977	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.