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510(k) K142447

PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch by Synovis Life Technologies, Inc. — Product Code DXZ

K142447 is an FDA 510(k) premarket notification submitted by Synovis Life Technologies, Inc. for the device "PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch". The FDA issued a decision of Substantially Equivalent on January 7, 2015. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), 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
January 7, 2015
Date Received
September 2, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class
Class II
Regulation Number
870.3470
Review Panel
CV
Submission Type

Other clearances by Synovis Life Technologies, Inc.

  • K223052 — Peri-Guard and Supple Peri-Guard (April 7, 2023)
  • K221032 — Vascu-Guard Vascular Repair Patch (October 19, 2022)
  • K221029 — PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch (October 19, 2022)
  • K143589 — GEM Flow COUPLER Device and System (January 16, 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 DXZ

  • K240775 — PeriBeam® Pericardial Membrane (April 18, 2025)
  • K200955 — Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch (July 8, 2020)
  • K162506 — PhotoFix Decellularized Bovine Pericardium (March 9, 2017)
  • K162579 — VascuCel (October 14, 2016)
  • K152127 — CorMatrix Tyke (February 4, 2016)
  • K151865 — PremiPatch PTFE Pledget (October 27, 2015)
  • K142461 — VASCU-GUARD Peripheral Vascular Patch (November 25, 2014)
  • K140789 — CORMATRIX ECM FOR VASCULAR REPAIR (July 15, 2014)
  • K130872 — CARDIOCEL (January 30, 2014)
  • K122306 — SYNOVIS COLLAGEN MATRIX (TBD) (March 8, 2013)

FDA data resources