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FDA 510(k)

HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION

K-Number: K052302 · 2005-09-12

ApplicantBoston Scientific Corp
Decision Date2005-09-12
Product CodeMAL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION 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 2005-09-12 under 510(k) number K052302. 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 HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION?

HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION is a medical device that received FDA 510(k) clearance on 2005-09-12. The listed applicant is Boston Scientific Corp. The 510(k) number is K052302.

When did HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION receive FDA 510(k) clearance?

HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION received FDA 510(k) clearance on 2005-09-12, under 510(k) number K052302.

Who is the listed applicant for HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION?

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 HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION?

The FDA product code for HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION is MAL.

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Related Devices (Code: MAL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K122612HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXXMaquet Cardiovascular, LLCK103080ALBOGRAFT VASCULAR PROSTHESISLeMaitre Vascular, Inc.K093231ALBOGRAFT VASCULAR PROSTHESISLeMaitre Vascular, Inc.K021213MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTSBoston Scientific CorpK954848HEMASHIELD 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.

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