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510(k) K122306

SYNOVIS COLLAGEN MATRIX (TBD) by Synovis Surgical Innovations — Product Code DXZ

K122306 is an FDA 510(k) premarket notification submitted by Synovis Surgical Innovations for the device "SYNOVIS COLLAGEN MATRIX (TBD)". The FDA issued a decision of Substantially Equivalent on March 8, 2013. 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 Surgical Innovations has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2013
Date Received
August 1, 2012
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 Surgical Innovations

  • K083039 — VERITAS COLLAGEN MATRIX (DRY) (November 26, 2008)
  • K062915 — VERITAS COLLAGEN MATRIX (December 6, 2006)
  • K041669 — VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD (October 27, 2004)
  • K040415 — PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PE (April 14, 2004)
  • K040119 — PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE L (March 17, 2004)
  • K040001 — STEERABLE STYLET (March 9, 2004)
  • K030879 — VERITAS COLLAGEN MATRIX (April 24, 2003)

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)
  • K142447 — PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch (January 7, 2015)
  • K142461 — VASCU-GUARD Peripheral Vascular Patch (November 25, 2014)
  • K140789 — CORMATRIX ECM FOR VASCULAR REPAIR (July 15, 2014)
  • K130872 — CARDIOCEL (January 30, 2014)

FDA data resources