The following data is part of a premarket notification filed by Ra Medical Systems, Inc. with the FDA for Dabra Laser System (dabra Laser Model Ra-308 And Dabra Catheter Model 101).
| Device ID | K210664 |
| 510k Number | K210664 |
| Device Name: | DABRA Laser System (DABRA Laser Model RA-308 And DABRA Catheter Model 101) |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | Ra Medical Systems, Inc. 2070 Las Palmas Drive Carlsbad, CA 92011 |
| Contact | Jami Miller |
| Correspondent | Jami Miller Ra Medical Systems, Inc. 2070 Las Palmas Drive Carlsbad, CA 92011 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-05 |
| Decision Date | 2021-07-27 |