K972113 is an FDA 510(k) clearance for the 30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL. This device is classified as a System, Balloon, Intra-aortic And Control (Class II - Special Controls, product code DSP).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on September 2, 1997, 89 days after receiving the submission on June 5, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3535.
| 510(k) Number | K972113 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 1997 |
| Decision Date | September 02, 1997 |
| Days to Decision | 89 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 |