FDA 510(k)

MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS

K-Number: K021213 · 2002-04-19

Decision Date2002-04-19

Product CodeMAL

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2002-04-19 under 510(k) number K021213. 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 MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS?

MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS is a medical device that received FDA 510(k) clearance on 2002-04-19. The listed applicant is Boston Scientific Corp. The 510(k) number is K021213.

When did MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS receive FDA 510(k) clearance?

MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS received FDA 510(k) clearance on 2002-04-19, under 510(k) number K021213.

Who is the listed applicant for MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS?

The FDA product code for MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS 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.K093231ALBOGRAFT VASCULAR PROSTHESISLeMaitre Vascular, Inc.K052302HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATIONBoston 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.