K890045 is an FDA 510(k) clearance for the MODEL 6208,6209,6210,6211,6212,6214 (PLI'S). This device is classified as a Permanent Pacemaker Electrode (Class III - Premarket Approval, product code DTB).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on January 30, 1989, 25 days after receiving the submission on January 5, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K890045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 1989 |
| Decision Date | January 30, 1989 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTB — Permanent Pacemaker Electrode |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.3680 |