Submission Details
| 510(k) Number | K031569 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 20, 2003 |
| Decision Date | June 10, 2003 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
Jun 2003
Decision
21d
Days
Class 2
Risk
About This 510(k) Submission
K031569 is an FDA 510(k) clearance for the DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX, a System, Balloon, Intra-aortic And Control (Class II — Special Controls, product code DSP), submitted by Datascope Corp. (Fairfield, US). The FDA issued a Cleared decision on June 10, 2003, 21 days after receiving the submission on May 20, 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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