Cleared Traditional

B-Laser Atherectomy System (K181642) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K181642 · Eximo Medical, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
106d
Days
Class 2
Risk

K181642 is an FDA 510(k) clearance for the B-Laser Atherectomy System. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Eximo Medical, Ltd. (Rehovot, IL). The FDA issued a Cleared decision on October 5, 2018 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Eximo Medical, Ltd. devices

Submission Details

510(k) Number K181642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2018
Decision Date October 05, 2018
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MCW Catheter, Peripheral, Atherectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice M. Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02556255 Completed Interventional Industry-sponsored

Safety and Effectiveness Study of Eximo's B-Laser™ Atherectomy Device for PAD Treatment

Safety and Effectiveness Evaluation of Eximo's B-Laser™ Atherectomy Device, in Subjects Affected With PAD

57
Patients (actual)
2
Sites
Treatment
Purpose
Open label
Masking
Condition studied Peripheral Arterial Disease
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Oshrat Cohen, Ph.D., MBA
Sponsor Eximo Medical Ltd. (industry)
Started 2015-10-01 → Primary completion 2017-08-01 → Completed 2020-11-20
Primary outcome
Number of Participants With 30 Day Freedom From Major Adverse Events
Secondary outcome
Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (2)
View full study on ClinicalTrials.gov

Regulatory Peers - MCW Catheter, Peripheral, Atherectomy

All 39
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K181642.
Phoenix Atherectomy System
K182972 · Volcano Atheromed, Inc. · Dec 2018
Phoenix 2.4mm Atherectomy Plus System
K181877 · Volcano Atheromed, Inc. · Dec 2018
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
K182397 · Cardiovascular Systems, Inc. · Dec 2018
Pantheris System
K173862 · Avinger, Inc. · May 2018
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
K180416 · Cardiovascular Systems, Inc. · Apr 2018
Straub Endovascular System
K172315 · Straub Medical AG · Apr 2018