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FDA 510(k)

B-Laser Atherectomy System

K-Number: K181642 · 2018-10-05

ApplicantEximo Medical, Ltd.
Decision Date2018-10-05
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

B-Laser Atherectomy System is a medical device manufactured by Eximo Medical, Ltd.. It received FDA 510(k) clearance on 2018-10-05 under approval number K181642. 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 B-Laser Atherectomy System?

B-Laser Atherectomy System is a medical device that received FDA 510(k) clearance on 2018-10-05. It is manufactured by Eximo Medical, Ltd.. The 510(k) number is K181642.

When was B-Laser Atherectomy System approved by the FDA?

B-Laser Atherectomy System received FDA 510(k) clearance on 2018-10-05, under approval number K181642.

What company makes B-Laser Atherectomy System?

B-Laser Atherectomy System is manufactured by Eximo Medical, Ltd..

What is the FDA product code for B-Laser Atherectomy System?

The FDA product code for B-Laser Atherectomy System is MCW.

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Other Devices by Eximo Medical, Ltd.

K202835Auryon Atherectomy System K220116Auryon Atherectomy Catheters K221077Auryon Atherectomy System K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000) K230709Auryon Atherectomy System K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating

View all 7 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. 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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