Submission Details
| 510(k) Number | K133074 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 30, 2013 |
| Decision Date | December 12, 2013 |
| Days to Decision | 73 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
Dec 2013
Decision
73d
Days
Class 2
Risk
About This 510(k) Submission
K133074 is an FDA 510(k) clearance for the MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES, 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 December 12, 2013, 73 days after receiving the submission on September 30, 2013. 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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