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510(k) K122612

HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX by Maquet Cardiovascular, LLC — Product Code MAL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2012
Date Received
August 27, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Graft, Vascular, Synthetic/Biologic Composite
Device Class
Class II
Regulation Number
870.3450
Review Panel
CV
Submission Type

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Other clearances for product code MAL

  • K103080 — ALBOGRAFT VASCULAR PROSTHESIS (January 19, 2011)
  • K093231 — ALBOGRAFT VASCULAR PROSTHESIS (January 14, 2010)
  • K052302 — HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION (September 12, 2005)
  • K021213 — MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS (April 19, 2002)
  • K954848 — HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT (February 1, 1996)