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510(k) K103080

ALBOGRAFT VASCULAR PROSTHESIS by LeMaitre Vascular, Inc. — Product Code MAL

K103080 is an FDA 510(k) premarket notification submitted by LeMaitre Vascular, Inc. for the device "ALBOGRAFT VASCULAR PROSTHESIS". The FDA issued a decision of Substantially Equivalent on January 19, 2011. The device falls under product code MAL (Graft, Vascular, Synthetic/Biologic Composite), a Class II device regulated under 21 CFR 870.3450. LeMaitre Vascular, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2011
Date Received
October 19, 2010
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 LeMaitre Vascular, Inc.

  • K212894 — PhasTIPP (March 31, 2022)
  • K190882 — XenoSure Biologic Patch (February 13, 2020)
  • K190267 — EZE SIT Valvulotome (October 30, 2019)
  • K183513 — XenoSure Dura Biologic Patch (June 13, 2019)
  • K182916 — Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid (November 16, 2018)
  • K173323 — AnastoClip GC Closure System (March 8, 2018)
  • K152833 — Pruitt F3-S Polyurethane Carotid Shunt (January 21, 2016)
  • K143454 — Pruitt F3-S Carotid Shunt (August 27, 2015)
  • K142660 — Antegrade LeMills Valvulotome (October 17, 2014)
  • K140042 — 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME (April 10, 2014)

Other clearances for product code MAL

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

FDA data resources