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FDA 510(k)

TightRail Guardian Motorized Dilator Sheath

K-Number: K212784 · 2022-08-24

ApplicantSpectranetics, Inc.
Decision Date2022-08-24
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TightRail Guardian Motorized Dilator Sheath is a medical device manufactured by Spectranetics, Inc.. It received FDA 510(k) clearance on 2022-08-24 under approval number K212784. 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 Guardian Motorized Dilator Sheath?

TightRail Guardian Motorized Dilator Sheath is a medical device that received FDA 510(k) clearance on 2022-08-24. It is manufactured by Spectranetics, Inc.. The 510(k) number is K212784.

When was TightRail Guardian Motorized Dilator Sheath approved by the FDA?

TightRail Guardian Motorized Dilator Sheath received FDA 510(k) clearance on 2022-08-24, under approval number K212784.

What company makes TightRail Guardian Motorized Dilator Sheath?

TightRail Guardian Motorized Dilator Sheath is manufactured by Spectranetics, Inc..

What is the FDA product code for TightRail Guardian Motorized Dilator Sheath?

The FDA product code for TightRail Guardian Motorized Dilator Sheath is DRE.

Other Devices by Spectranetics, Inc.

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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. K162389Medcomp Vessel DilatorMedcomp ( Medical Components) K170616van Andel Dilatation CatheterCook Incorporated

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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