K000210 is an FDA 510(k) clearance for the MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT. This device is classified as a Pacemaker Lead Adaptor (Class II - Special Controls, product code DTD).
Submitted by Medtronic Vascular (Shoreview, US). The FDA issued a Cleared decision on February 23, 2000, 30 days after receiving the submission on January 24, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3620.
| 510(k) Number | K000210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | January 24, 2000 |
| Decision Date | February 23, 2000 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTD — Pacemaker Lead Adaptor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3620 |