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510(k) K200955

Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch by Vascutek, Ltd. — Product Code DXZ

K200955 is an FDA 510(k) premarket notification submitted by Vascutek, Ltd. for the device "Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch". The FDA issued a decision of Substantially Equivalent on July 8, 2020. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), a Class II device regulated under 21 CFR 870.3470. Vascutek, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2020
Date Received
April 9, 2020
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 Vascutek, Ltd.

  • K241550 — Gelweave™ Vascular Prostheses (February 27, 2025)
  • K241070 — Gelsoft™ Plus Vascular Prostheses (November 15, 2024)
  • K202703 — Vascutek Gelsoft Plus ERS Vascular Graft (April 6, 2021)
  • K162803 — Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts (July 14, 2017)
  • K162794 — Gelweave Vascular Grafts (June 30, 2017)
  • K093817 — GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS (January 7, 2010)
  • K092863 — MAXIFLO, TAPERFLO (October 8, 2009)
  • K091778 — VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS (August 31, 2009)
  • K090987 — VASCUTEK BRANCHED GELWEAVE (June 19, 2009)
  • K081560 — VASCUTEK CANNULA GRAFT, MODEL CGS2008S (February 10, 2009)

Other clearances for product code DXZ

  • K240775 — PeriBeam® Pericardial Membrane (April 18, 2025)
  • 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)
  • K122306 — SYNOVIS COLLAGEN MATRIX (TBD) (March 8, 2013)

FDA data resources