The following data is part of a premarket notification filed by Cardiac Control Systems, Inc. with the FDA for Ccds Maestro(r) Ii Series 200 Cadiac Pacemaker.
| Device ID | K946188 |
| 510k Number | K946188 |
| Device Name: | CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | CARDIAC CONTROL SYSTEMS, INC. 3 COMMERCE BLVD. Palm Coast, FL 32164 |
| Contact | Terry C Mcmahon |
| Correspondent | Terry C Mcmahon CARDIAC CONTROL SYSTEMS, INC. 3 COMMERCE BLVD. Palm Coast, FL 32164 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-20 |
| Decision Date | 1995-05-15 |