K041993 is an FDA 510(k) clearance for the 2 CM PERIPHERAL CUTTING BALOON. This device is classified as a Catheter, Percutaneous, Cutting/scoring (Class II - Special Controls, product code PNO).
Submitted by Boston Scientific Ivt (San Diego, US). The FDA issued a Cleared decision on August 16, 2004, 24 days after receiving the submission on July 23, 2004.
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 | K041993 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2004 |
| Decision Date | August 16, 2004 |
| Days to Decision | 24 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 |