K922541 is an FDA 510(k) clearance for the USCI SUPER 9 PTCA GUIDING CATHETER. This device is classified as a Withdrawal/infusion Pump (Class II - Special Controls, product code DQI).
Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on December 8, 1992, 193 days after receiving the submission on May 29, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1800.
| 510(k) Number | K922541 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 1992 |
| Decision Date | December 08, 1992 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | DQI — Withdrawal/infusion Pump |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1800 |