The following data is part of a premarket notification filed by Ra Medical Systems, Inc. with the FDA for Ra-308 Excimer Laser System, Excimer Laser Catheter.
| Device ID | K170349 |
| 510k Number | K170349 |
| Device Name: | RA-308 Excimer Laser System, Excimer Laser Catheter |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | Ra Medical Systems, Inc. 1930 Kellogg Ave. Carlsbad, CA 92008 |
| Contact | Dean Irwin |
| Correspondent | Dean Irwin Ra Medical Systems, Inc. 1930 Kellogg Ave. Carlsbad, CA 92008 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-03 |
| Decision Date | 2017-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842362100031 | K170349 | 000 |
| 00842362100024 | K170349 | 000 |