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510(k) K040415

PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT by Synovis Surgical Innovations — Product Code DXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2004
Date Received
February 18, 2004
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

  • K122306 — SYNOVIS COLLAGEN MATRIX (TBD) (March 8, 2013)
  • 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)
  • 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)