The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Cardiosave Hybrid Intra-aortic Balloon Pump.
| Device ID | K151254 |
| 510k Number | K151254 |
| Device Name: | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump |
| 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 | 2015-05-12 |
| Decision Date | 2015-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607567111940 | K151254 | 000 |
| 10607567108414 | K151254 | 000 |
| 10607567108421 | K151254 | 000 |
| 10607567108438 | K151254 | 000 |
| 10607567108544 | K151254 | 000 |
| 10607567108551 | K151254 | 000 |
| 10607567109008 | K151254 | 000 |
| 10607567109053 | K151254 | 000 |
| 10607567109107 | K151254 | 000 |
| 10607567111117 | K151254 | 000 |
| 10607567111919 | K151254 | 000 |
| 10607567108391 | K151254 | 000 |