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510(k) K221032

Vascu-Guard Vascular Repair Patch by Synovis Life Technologies, Inc. — Product Code PSQ

K221032 is an FDA 510(k) premarket notification submitted by Synovis Life Technologies, Inc. for the device "Vascu-Guard Vascular Repair Patch". The FDA issued a decision of Substantially Equivalent on October 19, 2022. The device falls under product code PSQ (Intracardiac Patch Or Pledget, Biologically Derived), a Class II device regulated under 21 CFR 870.3470. Synovis Life Technologies, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2022
Date Received
April 7, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intracardiac Patch Or Pledget, Biologically Derived
Device Class
Class II
Regulation Number
870.3470
Review Panel
CV
Submission Type

To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.

Other clearances by Synovis Life Technologies, Inc.

  • K223052 — Peri-Guard and Supple Peri-Guard (April 7, 2023)
  • K221029 — PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch (October 19, 2022)
  • K143589 — GEM Flow COUPLER Device and System (January 16, 2015)
  • K142447 — PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch (January 7, 2015)
  • K142461 — VASCU-GUARD Peripheral Vascular Patch (November 25, 2014)
  • K142309 — GEM Flow COUPLER Device and System (September 16, 2014)
  • K132727 — GEM FLOW COUPLER DEVICE AND SYSTEM (October 22, 2013)
  • K130896 — VASCULAR PROBE, VASCULAR PROBE ES (April 24, 2013)

Other clearances for product code PSQ

  • K221029 — PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch (October 19, 2022)
  • K210331 — CardiaMend Pericardial and Epicardial Reconstruction Matrix (December 21, 2021)
  • K200566 — ADAPT Tissue (April 3, 2020)
  • K190882 — XenoSure Biologic Patch (February 13, 2020)
  • K191734 — MatriStem UBM Pericardial Patch (November 22, 2019)
  • K183635 — PhotoFix Decellularized Bovine Pericardium (February 14, 2019)
  • K181038 — CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm (October 10, 2018)
  • K172085 — PhotoFix Decellularized Bovine Pericardium (December 4, 2017)
  • K172660 — Duravess bovine pericardial vascular patch (November 17, 2017)
  • K170951 — CardioCel 3D (April 28, 2017)

FDA data resources