K850968 is an FDA 510(k) clearance for the MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN. This device is classified as a Pacemaker Lead Adaptor (Class II - Special Controls, product code DTD).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on August 29, 1985, 174 days after receiving the submission on March 8, 1985.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3620.
| 510(k) Number | K850968 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1985 |
| Decision Date | August 29, 1985 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTD — Pacemaker Lead Adaptor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3620 |