K981660 is an FDA 510(k) clearance for the Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters. This device is classified as a System, Balloon, Intra-aortic And Control (Class II - Special Controls, product code DSP).
Submitted by C.R. Bard, Inc. (Haverhill, US). The FDA issued a Cleared decision on October 16, 1998, 158 days after receiving the submission on May 11, 1998.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3535.
| 510(k) Number | K981660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 1998 |
| Decision Date | October 16, 1998 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| 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 |