K111295 is an FDA 510(k) clearance for the .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS. 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 May 31, 2011, 21 days after receiving the submission on May 10, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K111295 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2011 |
| Decision Date | May 31, 2011 |
| Days to Decision | 21 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 |