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FDA 510(k)

HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT

K-Number: K012952 · 2001-10-02

ApplicantBoston Scientific/Medi-Tech
Decision Date2001-10-02
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific/Medi-Tech. It received FDA 510(k) clearance on 2001-10-02 under 510(k) number K012952. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT?

HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT is a medical device that received FDA 510(k) clearance on 2001-10-02. The listed applicant is Boston Scientific/Medi-Tech. The 510(k) number is K012952.

When did HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT receive FDA 510(k) clearance?

HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT received FDA 510(k) clearance on 2001-10-02, under 510(k) number K012952.

Who is the listed applicant for HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT?

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

What is the FDA product code for HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT?

The FDA product code for HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT is DSY.

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Official Source

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

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