ALBOGRAFT VASCULAR PROSTHESIS— 510(k) K103080

Clearance details

Applicant

LeMaitre Vascular, Inc.

Product code

Code MAL

Device class

Class 2

Regulation

21 CFR 870.3450

Advisory panel

Cardiovascular

Date received

2010-10-19

Decision date

2011-01-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bedford, MA, US

• K122612 — HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX2012-09-10
• K093231 — ALBOGRAFT VASCULAR PROSTHESIS2010-01-14
• K052302 — HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION2005-09-12
• K021213 — MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS2002-04-19
• K954848 — HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT1996-02-01

• K212894 — PhasTIPP2022-03-31
• K183513 — XenoSure Dura Biologic Patch2019-06-13
• K173323 — AnastoClip GC Closure System2018-03-08
• K152833 — Pruitt F3-S Polyurethane Carotid Shunt2016-01-21
• K143454 — Pruitt F3-S Carotid Shunt2015-08-27

Death

4

Total

4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1754-2013 — AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.Class I·Terminated·LeMaitre Vascular, Inc.·20130617
• Z-1755-2013 — AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.Class I·Terminated·LeMaitre Vascular, Inc.·20130617
• Z-1756-2013 — Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.Class I·Terminated·LeMaitre Vascular, Inc.·20130617
• Z-1757-2013 — AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.Class I·Terminated·LeMaitre Vascular, Inc.·20130617
• Z-1758-2013 — AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.Class I·Terminated·LeMaitre Vascular, Inc.·20130617
• Z-1759-2013 — AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.Class I·Terminated·LeMaitre Vascular, Inc.·20130617
• Z-1760-2013 — AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.Class I·Terminated·LeMaitre Vascular, Inc.·20130617
• Z-1761-2013 — AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.Class I·Terminated·LeMaitre Vascular, Inc.·20130617
• Z-1762-2013 — AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.Class I·Terminated·LeMaitre Vascular, Inc.·20130617
• Z-1763-2013 — AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.Class I·Terminated·LeMaitre Vascular, Inc.·20130617
• Z-1764-2013 — AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.Class I·Terminated·LeMaitre Vascular, Inc.·20130617
• Z-1765-2013 — AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.Class I·Terminated·LeMaitre Vascular, Inc.·20130617
• Z-1766-2013 — AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.Class I·Terminated·LeMaitre Vascular, Inc.·20130617
• Z-1767-2013 — AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.Class I·Terminated·LeMaitre Vascular, Inc.·20130617
• Z-1768-2013 — AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.Class I·Terminated·LeMaitre Vascular, Inc.·20130617
• Z-1769-2013 — AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.Class I·Terminated·LeMaitre Vascular, Inc.·20130617
• Z-1770-2013 — AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.Class I·Terminated·LeMaitre Vascular, Inc.·20130617

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103080.