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)
Top companies in DXZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 25, 2025 | Glycar SA Pty., Ltd. SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE Open, Classified |
DXZ | K963967 |
| Nov 25, 2025 | Glycar SA Pty., Ltd. SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE Open, Classified |
DXZ | K963967 |
| Aug 8, 2024 | Artivion, 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 |
DXZ | K091626 |
| Jan 5, 2024 | Baxter 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 |
DXZ | K983602 |
| Jan 5, 2024 | Baxter 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 |
DXZ | K223052 |
| Jul 8, 2021 | Vascutek, Ltd. The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches.
FSN says Tapered Carotid Patch 920875t Terminated |
DXZ | K963611 K972201 |
| Nov 10, 2020 | CryoLife, 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 |
DXZ | K101866 |
| Sep 6, 2018 | CryoLife, Inc. CryoPatch SG Pulmonary Hemi-Artery, 1 graft Terminated |
DXZ | K091626 |
| May 14, 2018 | CryoLife, Inc. Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020 Terminated |
DXZ | K101866 |
| Mar 20, 2018 | GETINGE US SALES LLC HEMASHIELD Knitted Double Velour Cardiovascular Fabric Terminated |
DXZ | K955349 |
| Nov 21, 2016 | CryoLife, Inc. CryoPatch SG Pulmonary Hemi-Artery Patch Terminated |
DXZ | K091626 |
| Aug 12, 2016 | Baxter 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 |
DXZ | K983602 |
| May 29, 2015 | Synovis 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 |
DXZ | K142461 |
| Jan 23, 2014 | CryoLife, Inc. Pulmonary Hemi-Artery SG
Used in heart surgery Terminated |
DXZ | K101866 |
| Nov 18, 2013 | Synovis 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 |
DXZ | K983602 |
| Mar 4, 2011 | CryoLife, Inc. Pulmonary Hemi-Artery SG
Used in heart surgery Terminated |
DXZ | K101866 |
| Mar 4, 2011 | CryoLife, Inc. Pulmonary Valve & Conduit SG
Used in heart surgery Terminated |
DXZ | K092021 |
| Sep 21, 2010 | Synovis 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 |
DXZ | K040415 |
| Jul 22, 2010 | Maquet Cardiovascular, LLC Hemashield Double Velour Cardiovascular Fabrics. Terminated |
DXZ | K955349 |
| Jun 25, 2005 | Boston Scientific Scimed PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811,
M002000193821, M002000193931, M002000193841, M002000193861, M002000193881. Terminated |
DXZ | None listed |
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