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FDA 510(k)

Sheath Introducer

K-Number: K150932 · 2016-07-22

ApplicantBioteque Corp.
Decision Date2016-07-22
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sheath Introducer is a medical device manufactured by Bioteque Corp.. It received FDA 510(k) clearance on 2016-07-22 under approval number K150932. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sheath Introducer?

Sheath Introducer is a medical device that received FDA 510(k) clearance on 2016-07-22. It is manufactured by Bioteque Corp.. The 510(k) number is K150932.

When was Sheath Introducer approved by the FDA?

Sheath Introducer received FDA 510(k) clearance on 2016-07-22, under approval number K150932.

What company makes Sheath Introducer?

Sheath Introducer is manufactured by Bioteque Corp..

What is the FDA product code for Sheath Introducer?

The FDA product code for Sheath Introducer is DRE.

Related Devices (Code: DRE)

K161336VSI StraitSet micro-introducer kitVascular Solutions, Inc. K161333TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc. K172487Coaxial Dilator Set (Micro-Introducer)Galt Medical Corp. K162389Medcomp Vessel DilatorMedcomp ( Medical Components) K170616van Andel Dilatation CatheterCook Incorporated K162181Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetCardiacassist, Inc.

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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