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FDA 510(k)

PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch

K-Number: K221029 · 2022-10-19

ApplicantSynovis Life Technologies, Inc.
Decision Date2022-10-19
Product CodePSQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch is a medical device manufactured by Synovis Life Technologies, Inc.. It received FDA 510(k) clearance on 2022-10-19 under approval number K221029. The device is classified under product code PSQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch?

PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch is a medical device that received FDA 510(k) clearance on 2022-10-19. It is manufactured by Synovis Life Technologies, Inc.. The 510(k) number is K221029.

When was PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch approved by the FDA?

PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch received FDA 510(k) clearance on 2022-10-19, under approval number K221029.

What company makes PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch?

PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch is manufactured by Synovis Life Technologies, Inc..

What is the FDA product code for PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch?

The FDA product code for PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch is PSQ.

Related Clinical Trials

NCT05906004 Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff RECRUITING NCT06083181 Perf-Fix Study for Chronic Tympanic Membrane Repair COMPLETED

Other Devices by Synovis Life Technologies, Inc.

K221032Vascu-Guard Vascular Repair Patch K223052Peri-Guard and Supple Peri-Guard

Related Devices (Code: PSQ)

K172085PhotoFix Decellularized Bovine PericardiumCryolife, Inc. K172660Duravess bovine pericardial vascular patchEdwards Lifesciences, LLC K170951CardioCel 3DAdmedus Regen Pty, Ltd. K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)Cormatrix Cardiovascular, Inc. K191734MatriStem UBM Pericardial PatchAcell, Inc. K183635PhotoFix Decellularized Bovine PericardiumCryolife, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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