Submission Details
| 510(k) Number | K003598 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 21, 2000 |
| Decision Date | December 21, 2000 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320
Dec 2000
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K003598 is an FDA 510(k) clearance for the DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320, 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 21, 2000, 30 days after receiving the submission on November 21, 2000. 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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