Submission Details
| 510(k) Number | K041281 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 13, 2004 |
| Decision Date | June 07, 2004 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
Jun 2004
Decision
25d
Days
Class 2
Risk
About This 510(k) Submission
K041281 is an FDA 510(k) clearance for the DATASCOPE 7.5FR. IAB CATHETER 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 June 7, 2004, 25 days after receiving the submission on May 13, 2004. 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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