The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Percor Stat-dl 9.5 Fr. 34 & 40cc.
| Device ID | K960166 |
| 510k Number | K960166 |
| Device Name: | PERCOR STAT-DL 9.5 FR. 34 & 40CC |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Contact | Diane Deponte-arpino |
| Correspondent | Diane Deponte-arpino DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-16 |
| Decision Date | 1996-04-24 |
| Summary: | summary |