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FDA 510(k)

TightRail Sub-C Rotating Dilator Sheath

K-Number: K161333 · 2016-07-08

ApplicantSpectranetics, Inc.
Decision Date2016-07-08
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TightRail Sub-C Rotating Dilator Sheath is a medical device manufactured by Spectranetics, Inc.. It received FDA 510(k) clearance on 2016-07-08 under approval number K161333. 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 TightRail Sub-C Rotating Dilator Sheath?

TightRail Sub-C Rotating Dilator Sheath is a medical device that received FDA 510(k) clearance on 2016-07-08. It is manufactured by Spectranetics, Inc.. The 510(k) number is K161333.

When was TightRail Sub-C Rotating Dilator Sheath approved by the FDA?

TightRail Sub-C Rotating Dilator Sheath received FDA 510(k) clearance on 2016-07-08, under approval number K161333.

What company makes TightRail Sub-C Rotating Dilator Sheath?

TightRail Sub-C Rotating Dilator Sheath is manufactured by Spectranetics, Inc..

What is the FDA product code for TightRail Sub-C Rotating Dilator Sheath?

The FDA product code for TightRail Sub-C Rotating Dilator Sheath is DRE.

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Related Devices (Code: DRE)

K161336VSI StraitSet micro-introducer kitVascular Solutions, Inc. K150932Sheath IntroducerBioteque Corp. 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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