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FDA 510(k)

Turbo-Power (2.0mm) Laser Atherectomy Catheters

K-Number: K162561 · 2017-01-05

ApplicantSpectranetics, Inc.
Decision Date2017-01-05
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Turbo-Power (2.0mm) Laser Atherectomy Catheters is a medical device manufactured by Spectranetics, Inc.. It received FDA 510(k) clearance on 2017-01-05 under approval number K162561. 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-Power (2.0mm) Laser Atherectomy Catheters?

Turbo-Power (2.0mm) Laser Atherectomy Catheters is a medical device that received FDA 510(k) clearance on 2017-01-05. It is manufactured by Spectranetics, Inc.. The 510(k) number is K162561.

When was Turbo-Power (2.0mm) Laser Atherectomy Catheters approved by the FDA?

Turbo-Power (2.0mm) Laser Atherectomy Catheters received FDA 510(k) clearance on 2017-01-05, under approval number K162561.

What company makes Turbo-Power (2.0mm) Laser Atherectomy Catheters?

Turbo-Power (2.0mm) Laser Atherectomy Catheters is manufactured by Spectranetics, Inc..

What is the FDA product code for Turbo-Power (2.0mm) Laser Atherectomy Catheters?

The FDA product code for Turbo-Power (2.0mm) Laser Atherectomy Catheters is MCW.

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Other Devices by Spectranetics, Inc.

K161333TightRail Sub-C Rotating Dilator Sheath K153530Bridge Occlusion Balloon K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters K170059Spectranetics Turbo-Elite Laser Atherectomy Catheters K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters K203540Bridge Occlusion Balloon

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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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