K862038 is an FDA 510(k) clearance for the MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER. This device is classified as a Implantable Pacemaker Pulse-generator (Class III - Premarket Approval, product code DXY).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on June 17, 1986, 20 days after receiving the submission on May 28, 1986.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3610.
| 510(k) Number | K862038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 1986 |
| Decision Date | June 17, 1986 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXY — Implantable Pacemaker Pulse-generator |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.3610 |