The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Cardiosave Intra-aortic Balloon Pump.
| Device ID | K181122 |
| 510k Number | K181122 |
| Device Name: | CARDIOSAVE Intra-Aortic Balloon Pump |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | Datascope Corp. 1300 MacArthur Blvd. Mahwah, NJ 07430 |
| Contact | Hemang Kotecha |
| Correspondent | Hemang Kotecha 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 | 2018-04-30 |
| Decision Date | 2018-05-31 |
| Summary: | summary |