The following data is part of a premarket notification filed by Cardiomedics, Inc. with the FDA for Cardiassist Counterpulsation System, Model Mark 3000.
| Device ID | K023427 |
| 510k Number | K023427 |
| Device Name: | CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 |
| Classification | Device, Counter-pulsating, External |
| Applicant | CARDIOMEDICS, INC. 18872 BARDEEN AVE. Irvine, CA 92612 |
| Contact | Gary Clark |
| Correspondent | Gary Clark CARDIOMEDICS, INC. 18872 BARDEEN AVE. Irvine, CA 92612 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-11 |
| Decision Date | 2003-01-07 |
| Summary: | summary |