K894976 is an FDA 510(k) clearance for the ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP.. 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 October 12, 1989, 66 days after receiving the submission on August 7, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3620.
| 510(k) Number | K894976 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 1989 |
| Decision Date | October 12, 1989 |
| Days to Decision | 66 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 |