K973013 is an FDA 510(k) clearance for the OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by Vas-Cath, Inc. (Covington, US). The FDA issued a Cleared decision on June 19, 1998, 310 days after receiving the submission on August 13, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K973013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 1997 |
| Decision Date | June 19, 1998 |
| Days to Decision | 310 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 |