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FDA 510(k)

Spectranetics Turbo-Elite Laser Atherectomy Catheters

K-Number: K170059 · 2017-04-07

ApplicantSpectranetics, Inc.
Decision Date2017-04-07
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Spectranetics Turbo-Elite Laser Atherectomy Catheters is a medical device manufactured by Spectranetics, Inc.. It received FDA 510(k) clearance on 2017-04-07 under approval number K170059. 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 Spectranetics Turbo-Elite Laser Atherectomy Catheters?

Spectranetics Turbo-Elite Laser Atherectomy Catheters is a medical device that received FDA 510(k) clearance on 2017-04-07. It is manufactured by Spectranetics, Inc.. The 510(k) number is K170059.

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

Spectranetics Turbo-Elite Laser Atherectomy Catheters received FDA 510(k) clearance on 2017-04-07, under approval number K170059.

What company makes Spectranetics Turbo-Elite Laser Atherectomy Catheters?

Spectranetics Turbo-Elite Laser Atherectomy Catheters is manufactured by Spectranetics, Inc..

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

The FDA product code for Spectranetics Turbo-Elite 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 K162561Turbo-Power (2.0mm) 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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