Home / 510(k) Clearances / K021213

510(k) K021213

MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS by Boston Scientific Corp — Product Code MAL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2002
Date Received
April 17, 2002
Clearance Type
Special
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 Boston Scientific Corp

  • K252910 — Orca Air/Water and Suction Valves (October 9, 2025)
  • K251291 — Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery (July 3, 2025)
  • K250468 — iSLEEVE Introducer Set (March 20, 2025)
  • K242950 — WallFlex Biliary PLUS RX Stent System (December 6, 2024)
  • K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (October 18, 2024)
  • K242507 — OBSIDIO™ Conformable Embolic (October 3, 2024)
  • K240464 — WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX (August 30, 2024)
  • K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (April 29, 2024)
  • K234002 — ICEfx Cryoablation System (FPRCH8000-02) (March 13, 2024)
  • K232633 — Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Elec (November 28, 2023)

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)
  • K954848 — HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT (February 1, 1996)