K241683 is an FDA 510(k) clearance for the Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ). This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on July 10, 2024, 29 days after receiving the submission on June 11, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K241683 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2024 |
| Decision Date | July 10, 2024 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LIT — Catheter, Angioplasty, Peripheral, Transluminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |