The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Astra 2, Astra 3, 4 & 6.
| Device ID | K842394 |
| 510k Number | K842394 |
| Device Name: | ASTRA 2, ASTRA 3, 4 & 6 |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | CARDIAC PACEMAKERS, INC. P.O. BOX 43079 St. Paul , MN 55164 - |
| Contact | Ann Morrissey |
| Correspondent | Ann Morrissey CARDIAC PACEMAKERS, INC. P.O. BOX 43079 St. Paul , MN 55164 - |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-19 |
| Decision Date | 1984-10-17 |