PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch— 510(k) K221029

Name: FDA 510(k) clearance K221029
Creator: U.S. Food and Drug Administration
Published: 2022-10-19

Substantially Equivalent

Synovis Life Technologies, Inc.

FDA 510(k) clearance K221029 for PERI-GUARD Repair Patch, SUPPLE PERI-GUARD 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

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K221032 — Vascu-Guard Vascular 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.

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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 K221029

K-number listed on FDA's recall record

Z-0664-2024 — Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CMUS, TS c) PG0404: 4 X 4 CMUS, TS d) PG0608: 6 X 8CMUS, TS e) PG0814: 8 X 14 CMUS, 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 K221029.

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