510(k) K170349 ยท PDU Catheter For Crossing Total Occlusions
RA-308 Excimer Laser System, Excimer Laser Catheter
| Applicant | Ra Medical Systems,Inc, Carlsbad CA, US |
| Decision | Substantially Equivalent, May 24, 2017 |
| Received | Feb 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170349
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2020 | Ra Medical Systems, Inc. DABRA Laser (RA-308 Excimer Laser)
Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomati Terminated |
PDU | None listed |
| Jul 24, 2020 | Ra Medical Systems, Inc. DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease. Terminated |
PDU | None listed |
| Jul 4, 2020 | Ra Medical Systems, Inc. DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to Terminated |
PDU | None listed |
| Sep 19, 2019 | Ra Medical Systems, Inc. Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only
Revised Terminated |
PDU | None listed |
| Feb 15, 2018 | Ra Medical Systems Inc The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them.
The system is a self-cont Terminated |
PDU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.