Submission Details
| 510(k) Number | K172305 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 31, 2017 |
| Decision Date | October 12, 2017 |
| Days to Decision | 73 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
Oct 2017
Decision
73d
Days
Class 2
Risk
About This 510(k) Submission
K172305 is an FDA 510(k) clearance for the CS100/CS100i Intra-Aortic Balloon Pump, CS300 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 October 12, 2017, 73 days after receiving the submission on July 31, 2017. 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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