The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Model 5311b A-v Pacing System Analyzer.
| Device ID | K910595 |
| 510k Number | K910595 |
| Device Name: | MODEL 5311B A-V PACING SYSTEM ANALYZER |
| Classification | Analyzer, Pacemaker Generator Function |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Contact | Becky Savageau |
| Correspondent | Becky Savageau MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Product Code | DTC |
| CFR Regulation Number | 870.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-12 |
| Decision Date | 1991-05-07 |