FDA 510(k)

Medcomp Vessel Dilator

K-Number: K162389 · 2017-06-01

Decision Date2017-06-01

Product CodeDRE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Medcomp Vessel Dilator is a medical device manufactured by Medcomp ( Medical Components). It received FDA 510(k) clearance on 2017-06-01 under approval number K162389. 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 Medcomp Vessel Dilator?

Medcomp Vessel Dilator is a medical device that received FDA 510(k) clearance on 2017-06-01. It is manufactured by Medcomp ( Medical Components). The 510(k) number is K162389.

When was Medcomp Vessel Dilator approved by the FDA?

Medcomp Vessel Dilator received FDA 510(k) clearance on 2017-06-01, under approval number K162389.

What company makes Medcomp Vessel Dilator?

Medcomp Vessel Dilator is manufactured by Medcomp ( Medical Components).

What is the FDA product code for Medcomp Vessel Dilator?

The FDA product code for Medcomp Vessel Dilator is DRE.

Other Devices by Medcomp ( Medical Components)

K153238Dignity Dual Port

Related Devices (Code: DRE)

K161336VSI StraitSet micro-introducer kitVascular Solutions, Inc. K150932Sheath IntroducerBioteque Corp. K161333TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc. K172487Coaxial Dilator Set (Micro-Introducer)Galt Medical Corp. 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.