The following data is part of a premarket notification filed by Cardiac Control Systems, Inc. with the FDA for Maestro(r) Models 115, 118, 215 And 218 Pacemakers.
| Device ID | K880326 |
| 510k Number | K880326 |
| Device Name: | MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | CARDIAC CONTROL SYSTEMS, INC. 3 COMMERCE BLVD. Palm Coast, FL 32164 |
| Contact | Scott J Mindrebo |
| Correspondent | Scott J Mindrebo CARDIAC CONTROL SYSTEMS, INC. 3 COMMERCE BLVD. Palm Coast, FL 32164 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-26 |
| Decision Date | 1988-04-11 |