Submission Details
| 510(k) Number | K181642 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
B-Laser Atherectomy System
Oct 2018
Decision
106d
Days
Class 2
Risk
About This 510(k) Submission
K181642 is an FDA 510(k) clearance for the B-Laser Atherectomy System, a Catheter, Peripheral, Atherectomy (Class II — Special Controls, product code MCW), submitted by Eximo Medical, Ltd. (Rehovot, IL). The FDA issued a Cleared decision on October 5, 2018, 106 days after receiving the submission on June 21, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.
Device Classification
| Product Code | MCW — Catheter, Peripheral, Atherectomy |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4875 |
Manufacturer
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