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FDA 510(k)

Turbo-Elite Laser Atherectomy Catheter

K-Number: K250385 · 2025-03-13

ApplicantSpectranetics
Decision Date2025-03-13
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Turbo-Elite Laser Atherectomy Catheter is a medical device manufactured by Spectranetics. It received FDA 510(k) clearance on 2025-03-13 under approval number K250385. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Turbo-Elite Laser Atherectomy Catheter?

Turbo-Elite Laser Atherectomy Catheter is a medical device that received FDA 510(k) clearance on 2025-03-13. It is manufactured by Spectranetics. The 510(k) number is K250385.

When was Turbo-Elite Laser Atherectomy Catheter approved by the FDA?

Turbo-Elite Laser Atherectomy Catheter received FDA 510(k) clearance on 2025-03-13, under approval number K250385.

What company makes Turbo-Elite Laser Atherectomy Catheter?

Turbo-Elite Laser Atherectomy Catheter is manufactured by Spectranetics.

What is the FDA product code for Turbo-Elite Laser Atherectomy Catheter?

The FDA product code for Turbo-Elite Laser Atherectomy Catheter is MCW.

Related Clinical Trials

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Related Devices (Code: MCW)

K163264Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox SledAvinger, Inc. K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc. K161361HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc. K160827Pantheris CatheterAvinger, Inc. K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc. K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersSpectranetics, 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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