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510(k) K954848

HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT by Meadox Medicals, Div. Boston Scientific Corp. — Product Code MAL

K954848 is an FDA 510(k) premarket notification submitted by Meadox Medicals, Div. Boston Scientific Corp. for the device "HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT". The FDA issued a decision of ST on February 1, 1996. The device falls under product code MAL (Graft, Vascular, Synthetic/Biologic Composite), a Class II device regulated under 21 CFR 870.3450. Meadox Medicals, Div. Boston Scientific Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
February 1, 1996
Date Received
October 23, 1995
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

Other clearances by Meadox Medicals, Div. Boston Scientific Corp.

  • K953647 — MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING (May 16, 1997)
  • K960766 — MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT (March 19, 1997)
  • K962433 — MEADOX EXXCEL EPTFE VASCULAR GRAFT (March 17, 1997)
  • K961847 — HEMASHIELD VANTAGE (VASCULAR GRAFT (January 22, 1997)
  • K962342 — HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH (September 10, 1996)
  • K955460 — MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GR (May 30, 1996)
  • K952884 — NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER (February 21, 1996)
  • K955349 — HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC (February 14, 1996)
  • K953298 — MS CLASSIQUE BALLOON DIATATION CATHETER (February 8, 1996)
  • K953608 — NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER (December 20, 1995)

Other clearances for product code MAL

  • K122612 — HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXX (September 10, 2012)
  • 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)

FDA data resources