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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 the device name listed in this FDA 510(k) record. The listed applicant is Synovis Life Technologies, Inc.. It received FDA 510(k) clearance on 2022-10-19 under 510(k) 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. The listed applicant is Synovis Life Technologies, Inc.. The 510(k) number is K221029.

When did PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch receive FDA 510(k) clearance?

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

Who is the listed applicant for PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch?

The FDA 510(k) record lists Synovis Life Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Synovis Life Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223052Peri-Guard and Supple Peri-GuardK221032Vascu-Guard Vascular Repair Patch

Related Devices (Code: PSQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221032Vascu-Guard Vascular Repair PatchSynovis Life Technologies, Inc.K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.K200566ADAPT TissueAdmedus Regen Pty, Ltd.K190882XenoSure Biologic PatchLemaitre VascularK191734MatriStem 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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