K170349 is an FDA 510(k) clearance for the RA-308 Excimer Laser System, Excimer Laser Catheter. This device is classified as a Catheter For Crossing Total Occlusions (Class II - Special Controls, product code PDU).
Submitted by Ra Medical Systems,Inc (Carlsbad, US). The FDA issued a Cleared decision on May 24, 2017, 110 days after receiving the submission on February 3, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250. To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement..
| 510(k) Number | K170349 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2017 |
| Decision Date | May 24, 2017 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PDU - Catheter For Crossing Total Occlusions |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
| Definition | To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement. |