K811372 is an FDA 510(k) clearance for the MODEL 84 TRANSPORT SYSTEM. This device is classified as a System, Balloon, Intra-aortic And Control (Class II - Special Controls, product code DSP).
Submitted by Datascope Corp. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1981, 80 days after receiving the submission on May 15, 1981.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3535.
| 510(k) Number | K811372 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 1981 |
| Decision Date | August 03, 1981 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DSP - System, Balloon, Intra-aortic And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3535 |