K953522 is an FDA 510(k) clearance for the USCI IDEAL PTCA KIT. This device is classified as a Syringe, Balloon Inflation (Class II - Special Controls, product code MAV).
Submitted by Ryder Intl. Corp. (Brunswick, US). The FDA issued a Cleared decision on April 17, 1996, 265 days after receiving the submission on July 27, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K953522 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 1995 |
| Decision Date | April 17, 1996 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MAV — Syringe, Balloon Inflation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |