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FDA 510(k)

TEMPORARY LIMB SALVAGE SHUNT

K-Number: K070323 · 2007-02-15

ApplicantVascutek, Ltd.
Decision Date2007-02-15
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TEMPORARY LIMB SALVAGE SHUNT is the device name listed in this FDA 510(k) record. The listed applicant is Vascutek, Ltd.. It received FDA 510(k) clearance on 2007-02-15 under 510(k) number K070323. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPORARY LIMB SALVAGE SHUNT?

TEMPORARY LIMB SALVAGE SHUNT is a medical device that received FDA 510(k) clearance on 2007-02-15. The listed applicant is Vascutek, Ltd.. The 510(k) number is K070323.

When did TEMPORARY LIMB SALVAGE SHUNT receive FDA 510(k) clearance?

TEMPORARY LIMB SALVAGE SHUNT received FDA 510(k) clearance on 2007-02-15, under 510(k) number K070323.

Who is the listed applicant for TEMPORARY LIMB SALVAGE SHUNT?

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

What is the FDA product code for TEMPORARY LIMB SALVAGE SHUNT?

The FDA product code for TEMPORARY LIMB SALVAGE SHUNT is DXC.

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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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