ClearanceBrief
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)
2recalls in 12 months (20 all time)
19recalls that name a 510(k)
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Top companies in DXZ

DateFirm and productCodeLinked 510(k)
Nov 25, 2025Glycar SA Pty., Ltd.
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Open, Classified
DXZK963967
Nov 25, 2025Glycar SA Pty., Ltd.
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Open, Classified
DXZK963967
Aug 8, 2024Artivion, Inc
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmona
Open, Classified
DXZK091626
Jan 5, 2024Baxter Healthcare Corporation
Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM GLOBAL, d) VG0209N: 2X9 CM GLOBAL
Open, Classified
DXZK983602
Jan 5, 2024Baxter Healthcare Corporation
PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X 14 CM US, TS; e) PC1016SNBIO: 10X16 CM US; f) PC0404
Open, Classified
DXZK223052
Jul 8, 2021Vascutek, Ltd.
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
Terminated
DXZK963611
K972201
Nov 10, 2020CryoLife, Inc.
CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packagin
Terminated
DXZK101866
Sep 6, 2018CryoLife, Inc.
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Terminated
DXZK091626
May 14, 2018CryoLife, Inc.
Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
Terminated
DXZK101866
Mar 20, 2018GETINGE US SALES LLC
HEMASHIELD Knitted Double Velour Cardiovascular Fabric
Terminated
DXZK955349
Nov 21, 2016CryoLife, Inc.
CryoPatch SG Pulmonary Hemi-Artery Patch
Terminated
DXZK091626
Aug 12, 2016Baxter Healthcare Corp.
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, a
Terminated
DXZK983602
May 29, 2015Synovis Surgical Innovations, Inc.
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product cod
Terminated
DXZK142461
Jan 23, 2014CryoLife, Inc.
Pulmonary Hemi-Artery SG Used in heart surgery
Terminated
DXZK101866
Nov 18, 2013Synovis Surgical Innovations, Inc.
Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral vascular reconstruction. Product Code: VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N V
Terminated
DXZK983602
Mar 4, 2011CryoLife, Inc.
Pulmonary Hemi-Artery SG Used in heart surgery
Terminated
DXZK101866
Mar 4, 2011CryoLife, Inc.
Pulmonary Valve & Conduit SG Used in heart surgery
Terminated
DXZK092021
Sep 21, 2010Synovis Surgical Inovation Div. of
PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) and Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) products. Sterile,
Terminated
DXZK040415
Jul 22, 2010Maquet Cardiovascular, LLC
Hemashield Double Velour Cardiovascular Fabrics.
Terminated
DXZK955349
Jun 25, 2005Boston Scientific Scimed
PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861, M002000193881.
Terminated
DXZNone listed

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