K151253 is an FDA 510(k) clearance for the 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter. This device is classified as a Catheter, Percutaneous, Cutting/scoring (Class II - Special Controls, product code PNO).
Submitted by Boston Scientific Limited (Galway, IE). The FDA issued a Cleared decision on June 10, 2015, 29 days after receiving the submission on May 12, 2015.
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 | K151253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2015 |
| Decision Date | June 10, 2015 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |