Submission Details
| 510(k) Number | K031636 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 27, 2003 |
| Decision Date | August 11, 2003 |
| Days to Decision | 76 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Abbreviated
CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
Aug 2003
Decision
76d
Days
Class 2
Risk
About This 510(k) Submission
K031636 is an FDA 510(k) clearance for the CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX, a System, Balloon, Intra-aortic And Control (Class II — Special Controls, product code DSP), submitted by Datascope Corp. (Mahwah, US). The FDA issued a Cleared decision on August 11, 2003, 76 days after receiving the submission on May 27, 2003. 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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