K910595 is an FDA 510(k) clearance for the MODEL 5311B A-V PACING SYSTEM ANALYZER. This device is classified as a Analyzer, Pacemaker Generator Function (Class II - Special Controls, product code DTC).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on May 7, 1991, 84 days after receiving the submission on February 12, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3630.
| 510(k) Number | K910595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 1991 |
| Decision Date | May 07, 1991 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTC — Analyzer, Pacemaker Generator Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3630 |