Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters

K-Number: K172687 · 2017-11-27

ApplicantSpectranetics, Inc.
Decision Date2017-11-27
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters is a medical device manufactured by Spectranetics, Inc.. It received FDA 510(k) clearance on 2017-11-27 under approval number K172687. 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 (2.3mm) Laser Atherectomy Catheters?

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters is a medical device that received FDA 510(k) clearance on 2017-11-27. It is manufactured by Spectranetics, Inc.. The 510(k) number is K172687.

When was Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters approved by the FDA?

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters received FDA 510(k) clearance on 2017-11-27, under approval number K172687.

What company makes Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters?

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters is manufactured by Spectranetics, Inc..

What is the FDA product code for Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters?

The FDA product code for Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters is MCW.

Related Clinical Trials

NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING NCT07462169 High Intensity Laser VS High Power Pain Threshold Ultrasound in Treatment of Plantar Fasciitis RECRUITING NCT07535853 Effect of Low-Power Laser Therapy on Pain and Functional Outcomes in Patients With Thoracic Outlet Syndrome NOT_YET_RECRUITING

Other Devices by Spectranetics, Inc.

K161333TightRail Sub-C Rotating Dilator Sheath K153530Bridge Occlusion Balloon K170059Spectranetics Turbo-Elite 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

View all 11 devices →

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. K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox SledAvinger, 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.

↑