K070951 is an FDA 510(k) clearance for the 2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS. This device is classified as a Catheter, Percutaneous, Cutting/scoring (Class II - Special Controls, product code PNO).
Submitted by Boston Scientific (San Diego, US). The FDA issued a Cleared decision on June 4, 2007, 61 days after receiving the submission on April 4, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250. To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material.
| 510(k) Number | K070951 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2007 |
| Decision Date | June 04, 2007 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PNO — Catheter, Percutaneous, Cutting/scoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
| Definition | To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material |