Submission Details
| 510(k) Number | K910997 FDA.gov |
| FDA Decision | Not Cleared SI (SI) |
| Date Received | March 08, 1991 |
| Decision Date | November 05, 1991 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
Not Cleared
Traditional
K910997 - DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON (FDA 510(k) Clearance)
Nov 1991
Decision
242d
Days
Class 2
Risk
K910997 is an FDA 510(k) submission for the DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON. This device is classified as a System, Balloon, Intra-aortic And Control (Class II - Special Controls, product code DSP).
Submitted by Datascope Corp. (Oakland, US). The FDA issued a Not Cleared (DENG) decision on November 5, 1991.
This device falls under the Cardiovascular FDA 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 |