K953647 is an FDA 510(k) clearance for the MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on May 16, 1997, 651 days after receiving the submission on August 4, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K953647 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 1995 |
| Decision Date | May 16, 1997 |
| Days to Decision | 651 days |
| Submission Type | Traditional |
| 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 |