Submission Details
| 510(k) Number | K151254 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 12, 2015 |
| Decision Date | July 02, 2015 |
| Days to Decision | 51 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
Jul 2015
Decision
51d
Days
Class 2
Risk
About This 510(k) Submission
K151254 is an FDA 510(k) clearance for the CARDIOSAVE Hybrid Intra-Aortic Balloon Pump, a System, Balloon, Intra-aortic And Control (Class II — Special Controls, product code DSP), submitted by Datascope Corp. (Manwah, US). The FDA issued a Cleared decision on July 2, 2015, 51 days after receiving the submission on May 12, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3535.
Device Classification
| Product Code | DSP — System, Balloon, Intra-aortic And Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.3535 |
Manufacturer
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