K971034 is an FDA 510(k) clearance for the USCI MAINSTAY GUIDING CATHETER. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on May 28, 1997, 68 days after receiving the submission on March 21, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K971034 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1997 |
| Decision Date | May 28, 1997 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |