K911048 is an FDA 510(k) clearance for the MODEL 5857-3M LEAD END CAP KIT. 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 April 18, 1991, 41 days after receiving the submission on March 8, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3620.
| 510(k) Number | K911048 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1991 |
| Decision Date | April 18, 1991 |
| Days to Decision | 41 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 |