The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Cardiosave Hybrid And Rescue Intra-aortic Balloon Pump, Cardiosave Li-ion Battery Transport And Storage Case.
| Device ID | K163542 |
| 510k Number | K163542 |
| Device Name: | CARDIOSAVE Hybrid And Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport And Storage Case |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | Datascope Corp. 1300 MacArthur Blvd. Mahwah, NJ 07430 |
| Contact | Helder A. Sousa |
| Correspondent | Helder A. Sousa Datascope Corp. 1300 MacArthur Blvd. Mahwah, NJ 07430 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-16 |
| Decision Date | 2017-01-31 |
| Summary: | summary |