K831926 is an FDA 510(k) clearance for the IMPLANTABLE ENDOCARDIAL PACING LEADS. This device is classified as a Magnet, Test, Pacemaker (Class I - General Controls, product code DTG).
Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on March 12, 1984, 271 days after receiving the submission on June 15, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3690.
| 510(k) Number | K831926 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1983 |
| Decision Date | March 12, 1984 |
| Days to Decision | 271 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DTG - Magnet, Test, Pacemaker |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.3690 |