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FDA 510(k)

VSI StraitSet micro-introducer kit

K-Number: K161336 · 2016-08-11

ApplicantVascular Solutions, Inc.
Decision Date2016-08-11
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VSI StraitSet micro-introducer kit is a medical device manufactured by Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2016-08-11 under approval number K161336. 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 VSI StraitSet micro-introducer kit?

VSI StraitSet micro-introducer kit is a medical device that received FDA 510(k) clearance on 2016-08-11. It is manufactured by Vascular Solutions, Inc.. The 510(k) number is K161336.

When was VSI StraitSet micro-introducer kit approved by the FDA?

VSI StraitSet micro-introducer kit received FDA 510(k) clearance on 2016-08-11, under approval number K161336.

What company makes VSI StraitSet micro-introducer kit?

VSI StraitSet micro-introducer kit is manufactured by Vascular Solutions, Inc..

What is the FDA product code for VSI StraitSet micro-introducer kit?

The FDA product code for VSI StraitSet micro-introducer kit is DRE.

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Related Devices (Code: DRE)

K150932Sheath IntroducerBioteque Corp. 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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