K013326 is an FDA 510(k) clearance for the MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B. This device is classified as 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 November 2, 2001, 28 days after receiving the submission on October 5, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3535.
| 510(k) Number | K013326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 2001 |
| Decision Date | November 02, 2001 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSP - System, Balloon, Intra-aortic And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3535 |