The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope Intra-aortic Balloon With Modified Stat Gard.
| Device ID | K944460 |
| 510k Number | K944460 |
| Device Name: | DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Contact | Diane M Arpino |
| Correspondent | Diane M 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 | 1994-09-12 |
| Decision Date | 1994-12-09 |