Vascu-Guard Vascular Repair Patch— 510(k) K221032

Name: FDA 510(k) clearance K221032
Creator: U.S. Food and Drug Administration
Published: 2022-10-19

Substantially Equivalent

Synovis Life Technologies, Inc.

FDA 510(k) clearance K221032 for Vascu-Guard Vascular Repair Patch, Substantially Equivalent on 2022-10-19. Applicant: Synovis Life Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Synovis Life Technologies, Inc.
Product code: Code PSQ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2022-04-07
Decision date: 2022-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PSQ

view all

K221029 — PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch2022-10-19
K210331 — CardiaMend Pericardial and Epicardial Reconstruction Matrix2021-12-21
K200566 — ADAPT Tissue2020-04-03
K190882 — XenoSure Biologic Patch2020-02-13
K191734 — MatriStem UBM Pericardial Patch2019-11-22

More clearances from Synovis Life Technologies, Inc.

view all

K223052 — Peri-Guard and Supple Peri-Guard2023-04-07
K143589 — GEM Flow COUPLER Device and System2015-01-16
K142447 — PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch2015-01-07
K142461 — VASCU-GUARD Peripheral Vascular Patch2014-11-25
K142309 — GEM Flow COUPLER Device and System2014-09-16

Recalls naming K221032

K-number listed on FDA's recall record

Z-0666-2024 — Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, TS; c) VG0106: 1 X 6 CM US, TS; d) VG0209: 2 X 9 CM US, TSClass II·Ongoing·Baxter Healthcare Corporation·20231206

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K221032.

Data sourced from openFDA. This site is unofficial and independent of the FDA.