The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope Ca 40 8fr. Iabs, Model 0684-00-04xx.
| Device ID | K031569 |
| 510k Number | K031569 |
| Device Name: | DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Contact | Joann Taylor |
| Correspondent | Joann Taylor DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-20 |
| Decision Date | 2003-06-10 |
| Summary: | summary |