The following data is part of a premarket notification filed by Eximo Medical Ltd. with the FDA for B-laser Atherectomy System.
| Device ID | K181642 |
| 510k Number | K181642 |
| Device Name: | B-Laser Atherectomy System |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Eximo Medical Ltd. 3 Pekeris St. Rehovot, IL 7670203 |
| Contact | Yossi Muncher |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-21 |
| Decision Date | 2018-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290017590056 | K181642 | 000 |
| 07290017590066 | K181642 | 000 |
| 07290017590073 | K181642 | 000 |
| 07290017590080 | K181642 | 000 |
| 07290017590097 | K181642 | 000 |
| 17290017590001 | K181642 | 000 |
| 17290017590018 | K181642 | 000 |
| 17290017590025 | K181642 | 000 |
| 17290017590032 | K181642 | 000 |
| 17290017590049 | K181642 | 000 |
| 07290017590110 | K181642 | 000 |