K880323 is an FDA 510(k) clearance for the MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR. This device is classified as a Cable, Transducer And Electrode, Patient, (including Connector) (Class II - Special Controls, product code DSA).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on March 22, 1988, 56 days after receiving the submission on January 26, 1988.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2900.
| 510(k) Number | K880323 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 1988 |
| Decision Date | March 22, 1988 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DSA — Cable, Transducer And Electrode, Patient, (including Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2900 |