Identifiers
- 510(k) Number
- K181642 FDA 510(k)
- FDA Product Code
- MCW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4875 FDA 510(k)
- Regulation Number
- 870.4875 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The B-Laser Atherectomy System is a peripheral atherectomy catheter designed for use in the cardiovascular system. It functions as a medical device intended to remove plaque or other obstructions from peripheral arteries.
This device has received FDA 510(k) clearance. It is classified as a class 2 medical device under regulation number 870.4875.
Frequently asked questions
What is the primary function of the B-Laser Atherectomy System?
The B-Laser Atherectomy System is a peripheral atherectomy catheter designed for use within the cardiovascular system. Its primary function is to remove plaque or other obstructions from peripheral arteries to improve blood flow.
What is the regulatory status of this device?
The B-Laser Atherectomy System has received FDA 510(k) clearance. It is classified as a class 2 medical device under regulation number 870.4875, which pertains to peripheral atherectomy catheters.
Which medical specialty is this device associated with?
This device is categorized under the cardiovascular medical specialty. It is designed specifically for clinical applications involving the cardiovascular system, as indicated by its classification and advisory committee review.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: The Auryon Atherectomy System | AngioDynamics, Eximo Medical Ltd. Announces the First Successful Use of the B-Laser ..., FDA Clears Eximo Medical's B-Laser Atherectomy System to Treat ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181642 | Class II | Active |
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Manufacturer
- Manufacturer
- Eximo Medical Ltd
- FDA Applicant
- Eximo Medical, Ltd.
Sources (1)
- FDA 510(k) K181642 24 fields · synced Sep 27, 2026