FDA 510(k)

Vascu-Guard Vascular Repair Patch

K-Number: K221032 · 2022-10-19

ApplicantSynovis Life Technologies, Inc.

Decision Date2022-10-19

Product CodePSQ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Vascu-Guard Vascular 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 K221032. 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 Vascu-Guard Vascular Repair Patch?

Vascu-Guard Vascular 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 K221032.

When was Vascu-Guard Vascular Repair Patch approved by the FDA?

Vascu-Guard Vascular Repair Patch received FDA 510(k) clearance on 2022-10-19, under approval number K221032.

What company makes Vascu-Guard Vascular Repair Patch?

Vascu-Guard Vascular Repair Patch is manufactured by Synovis Life Technologies, Inc..

What is the FDA product code for Vascu-Guard Vascular Repair Patch?

The FDA product code for Vascu-Guard Vascular 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 NCT03332238 Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears ACTIVE_NOT_RECRUITING NCT06083181 Perf-Fix Study for Chronic Tympanic Membrane Repair COMPLETED NCT07528144 Exoskeleton vs. Standard Lead Apron in EVAR Procedures RECRUITING NCT05733585 Clinical Study of Patients Treated With PuraBond Haemostatic Agent During Abdominal Aorta Open Repair RECRUITING

Other Devices by Synovis Life Technologies, Inc.

K221029PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch K223052Peri-Guard and Supple Peri-Guard

Related Devices (Code: PSQ)

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Official Source

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