The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope Percor Stat - Dl 9.5 Fr. 25 And 40cc Intra-aortic Balloon For Optional Sheathless Insertion And Percor Stat -0.
| Device ID | K964987 |
| 510k Number | K964987 |
| Device Name: | DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Contact | Kevin Crossen |
| Correspondent | Kevin Crossen 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 | 1996-12-13 |
| Decision Date | 1997-03-17 |
| Summary: | summary |