FDA 510(k)

ALBOGRAFT VASCULAR PROSTHESIS

K-Number: K093231 · 2010-01-14

Decision Date2010-01-14

Product CodeMAL

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ALBOGRAFT VASCULAR PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is LeMaitre Vascular, Inc.. It received FDA 510(k) clearance on 2010-01-14 under 510(k) number K093231. The device is classified under product code MAL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALBOGRAFT VASCULAR PROSTHESIS?

ALBOGRAFT VASCULAR PROSTHESIS is a medical device that received FDA 510(k) clearance on 2010-01-14. The listed applicant is LeMaitre Vascular, Inc.. The 510(k) number is K093231.

When did ALBOGRAFT VASCULAR PROSTHESIS receive FDA 510(k) clearance?

ALBOGRAFT VASCULAR PROSTHESIS received FDA 510(k) clearance on 2010-01-14, under 510(k) number K093231.

Who is the listed applicant for ALBOGRAFT VASCULAR PROSTHESIS?

The FDA 510(k) record lists LeMaitre Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALBOGRAFT VASCULAR PROSTHESIS?

The FDA product code for ALBOGRAFT VASCULAR PROSTHESIS is MAL.

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Related Devices (Code: MAL)

K122612HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXXMaquet Cardiovascular, LLC K103080ALBOGRAFT VASCULAR PROSTHESISLeMaitre Vascular, Inc.K052302HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATIONBoston Scientific Corp K021213MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTSBoston Scientific Corp K954848HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFTMeadox Medicals, Div. Boston Scientific Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.