VASCU-GUARD Peripheral Vascular Patch— 510(k) K142461

Clearance details

Applicant

Synovis Life Technologies, Inc.

Product code

Code DXZ

Device class

Class 2

Regulation

21 CFR 870.3470

Advisory panel

Cardiovascular

Date received

2014-09-02

Decision date

2014-11-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

St. Paul, MN, US

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• K162506 — PhotoFix Decellularized Bovine Pericardium2017-03-09
• K162579 — VascuCel2016-10-14
• K152127 — CorMatrix Tyke2016-02-04

• K223052 — Peri-Guard and Supple Peri-Guard2023-04-07
• K221029 — PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch2022-10-19
• K221032 — Vascu-Guard Vascular Repair Patch2022-10-19
• K143589 — GEM Flow COUPLER Device and System2015-01-16
• K142447 — PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch2015-01-07

Death

19

Injury

265

Total

284

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1637-2015 — 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 code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.Class I·Terminated·Synovis Surgical Innovations, Inc.·20150502

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142461.