K131914 is an FDA 510(k) clearance for the OFFROAD RE-ENTRY CATHETER SYSTEM. This device is classified as a Catheter For Crossing Total Occlusions (Class II - Special Controls, product code PDU).
Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on October 31, 2013, 127 days after receiving the submission on June 26, 2013.
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 | K131914 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2013 |
| Decision Date | October 31, 2013 |
| Days to Decision | 127 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. |