The following data is part of a premarket notification filed by Datascope Corp., Cardiac Assist Division with the FDA for Datascope's 8fr. 50cc Intra-aortic Balloon Catheter And Accessories, Models 0684,00-0498-01, 02.
| Device ID | K091449 |
| 510k Number | K091449 |
| Device Name: | DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP., CARDIAC ASSIST DIVISION 15 LAW DR. Fairfield, NJ 07004 -0011 |
| Contact | Dolly Mistry |
| Correspondent | Dolly Mistry DATASCOPE CORP., CARDIAC ASSIST DIVISION 15 LAW DR. Fairfield, NJ 07004 -0011 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-18 |
| Decision Date | 2009-06-18 |
| Summary: | summary |