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FDA 510(k)

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer

K-Number: K153533 · 2016-07-05

ApplicantGalt Medical Corp.
Decision Date2016-07-05
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer is a medical device manufactured by Galt Medical Corp.. It received FDA 510(k) clearance on 2016-07-05 under approval number K153533. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tearaway Introducer Sheath, MicroSlide Tearaway Introducer?

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer is a medical device that received FDA 510(k) clearance on 2016-07-05. It is manufactured by Galt Medical Corp.. The 510(k) number is K153533.

When was Tearaway Introducer Sheath, MicroSlide Tearaway Introducer approved by the FDA?

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer received FDA 510(k) clearance on 2016-07-05, under approval number K153533.

What company makes Tearaway Introducer Sheath, MicroSlide Tearaway Introducer?

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer is manufactured by Galt Medical Corp..

What is the FDA product code for Tearaway Introducer Sheath, MicroSlide Tearaway Introducer?

The FDA product code for Tearaway Introducer Sheath, MicroSlide Tearaway Introducer is DYB.

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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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