The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Percor Stat Dl 8.5 Fr 40cc Intra-aortic Balloon.
| Device ID | K911000 |
| 510k Number | K911000 |
| Device Name: | PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland, NJ 07436 |
| Contact | Bill Corrigan |
| Correspondent | Bill Corrigan DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland, NJ 07436 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-08 |
| Decision Date | 1993-08-25 |