Submission Details
| 510(k) Number | K922541 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
USCI SUPER 9 PTCA GUIDING CATHETER
Dec 1992
Decision
193d
Days
Class 2
Risk
About This 510(k) Submission
K922541 is an FDA 510(k) clearance for the USCI SUPER 9 PTCA GUIDING CATHETER, 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 review panel. Regulated under 21 CFR 870.1800.
Device Classification
| Product Code | DQI — Withdrawal/infusion Pump |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1800 |
Manufacturer
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