FDA 510(k)

Coaxial Dilator Set (Micro-Introducer)

K-Number: K172487 · 2017-10-16

Decision Date2017-10-16

Product CodeDRE

Advisory CommitteeCV

DecisionUnknown

Device Summary

Coaxial Dilator Set (Micro-Introducer) is a medical device manufactured by Galt Medical Corp.. It received FDA 510(k) clearance on 2017-10-16 under approval number K172487. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Coaxial Dilator Set (Micro-Introducer)?

Coaxial Dilator Set (Micro-Introducer) is a medical device that received FDA 510(k) clearance on 2017-10-16. It is manufactured by Galt Medical Corp.. The 510(k) number is K172487.

When was Coaxial Dilator Set (Micro-Introducer) approved by the FDA?

Coaxial Dilator Set (Micro-Introducer) received FDA 510(k) clearance on 2017-10-16, under approval number K172487.

What company makes Coaxial Dilator Set (Micro-Introducer)?

Coaxial Dilator Set (Micro-Introducer) is manufactured by Galt Medical Corp..

What is the FDA product code for Coaxial Dilator Set (Micro-Introducer)?

The FDA product code for Coaxial Dilator Set (Micro-Introducer) is DRE.

Other Devices by Galt Medical Corp.

K153533Tearaway Introducer Sheath, MicroSlide Tearaway Introducer K173287Elite HV Radial K192195Sterile Dilator K182660GaltTWS

Related Devices (Code: DRE)

K161336VSI StraitSet micro-introducer kitVascular Solutions, Inc. K150932Sheath IntroducerBioteque Corp. K161333TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc. K162389Medcomp Vessel DilatorMedcomp ( Medical Components) K170616van Andel Dilatation CatheterCook Incorporated K162181Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetCardiacassist, Inc.

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.