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510(k) K961847

HEMASHIELD VANTAGE (VASCULAR GRAFT by Meadox Medicals, Div. Boston Scientific Corp. — Product Code DSY

K961847 is an FDA 510(k) premarket notification submitted by Meadox Medicals, Div. Boston Scientific Corp. for the device "HEMASHIELD VANTAGE (VASCULAR GRAFT". The FDA issued a decision of ST on January 22, 1997. The device falls under product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater 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
January 22, 1997
Date Received
May 13, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater 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)
  • K960766 — MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT (March 19, 1997)
  • K962433 — MEADOX EXXCEL EPTFE VASCULAR GRAFT (March 17, 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 DSY

  • K252445 — Fusion Bioline Vascular Graft (April 27, 2026)
  • K252277 — Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) (October 20, 2025)
  • K241550 — Gelweave™ Vascular Prostheses (February 27, 2025)
  • K241070 — Gelsoft™ Plus Vascular Prostheses (November 15, 2024)
  • K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft (March 28, 2024)
  • K240083 — GORE® PROPATEN® Vascular Graft (March 1, 2024)
  • K233783 — exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts (January 17, 2024)
  • K232312 — GORE® PROPATEN® Vascular Graft (January 9, 2024)
  • K233551 — GORE® ACUSEAL Vascular Graft (December 19, 2023)
  • K231505 — GORE® ACUSEAL Vascular Graft (June 23, 2023)

FDA data resources