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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 the device name listed in this FDA 510(k) record. The listed applicant is Eximo Medical, Ltd.. It received FDA 510(k) clearance on 2018-10-05 under 510(k) 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. The listed applicant is Eximo Medical, Ltd.. The 510(k) number is K181642.

When did B-Laser Atherectomy System receive FDA 510(k) clearance?

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

Who is the listed applicant for B-Laser Atherectomy System?

The FDA 510(k) record lists Eximo Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Eximo Medical, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260244Auryon Atherectomy SystemK241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingK233668Auryon 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 SystemK220116Auryon Atherectomy CathetersK221077Auryon Atherectomy System

View all 8 devices →

Related Devices (Code: MCW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260244Auryon Atherectomy SystemEximo MedicalK250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc.,K250385Turbo-Elite Laser Atherectomy CatheterSpectraneticsK242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.

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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