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510(k) K090637

CARDIO-WRAP by Mast Biosurgery USA, Inc. — Product Code DXZ

K090637 is an FDA 510(k) premarket notification submitted by Mast Biosurgery USA, Inc. for the device "CARDIO-WRAP". The FDA issued a decision of SESU on January 7, 2010. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), a Class II device regulated under 21 CFR 870.3470. Mast Biosurgery USA, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
January 7, 2010
Date Received
March 10, 2009
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 Mast Biosurgery USA, Inc.

  • K063648 — SURGI-WRAP MAST TENDON SHEET (March 7, 2007)
  • K061473 — SURGI-WRAP MAST BIORESORBABLE SHEET (September 21, 2006)
  • K050332 — SURGI-WRAP MAST BIORESORBABLE SHEET (May 27, 2005)

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