Submission Details
| 510(k) Number | K181122 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 30, 2018 |
| Decision Date | May 31, 2018 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
CARDIOSAVE Intra-Aortic Balloon Pump
May 2018
Decision
31d
Days
Class 2
Risk
About This 510(k) Submission
K181122 is an FDA 510(k) clearance for the CARDIOSAVE 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 May 31, 2018, 31 days after receiving the submission on April 30, 2018. 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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