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510(k) K960766

MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT by Meadox Medicals, Div. Boston Scientific Corp. — Product Code DYF

K960766 is an FDA 510(k) premarket notification submitted by Meadox Medicals, Div. Boston Scientific Corp. for the device "MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT". The FDA issued a decision of ST on March 19, 1997. The device falls under product code DYF (Prosthesis, Vascular Graft, Of Less Then 6mm Diameter), 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
March 19, 1997
Date Received
February 26, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
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)
  • 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)
  • K954848 — HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT (February 1, 1996)
  • K953608 — NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER (December 20, 1995)

Other clearances for product code DYF

  • K004012 — IMPRA CARBOFLO EPTFE VASCULAR GRAFTS (May 14, 2001)
  • K000504 — ADVANTA SUPER SOFT GRAFT (March 1, 2000)
  • K992958 — ADVANTA GRAFT (<6MM) (October 1, 1999)
  • K991683 — PTFE RINGED GORE-TEX VASCULAR GRAFT (September 8, 1999)
  • K992441 — ADVANTA GRAFT (August 20, 1999)
  • K984183 — PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 (February 1, 1999)
  • K983769 — DISTAFLO BYPASS GRAFT (December 15, 1998)
  • K981076 — VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT (May 7, 1998)
  • K964877 — IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (March 20, 1997)
  • K955533 — DIASTAT VASCULAR ACCESS GRAFT (May 15, 1996)

FDA data resources