K901780 is an FDA 510(k) clearance for the RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE. This device is classified as a Cable, Transducer And Electrode, Patient, (including Connector) (Class II - Special Controls, product code DSA).
Submitted by Medtronic Vascular (Haverhill, US). The FDA issued a Cleared decision on October 9, 1990, 175 days after receiving the submission on April 17, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2900.
| 510(k) Number | K901780 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 1990 |
| Decision Date | October 09, 1990 |
| Days to Decision | 175 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 |