The following data is part of a premarket notification filed by Datascope Corp., Cardiac Assist Division with the FDA for Sensation Plus 7.5fr. 40cc Intra-aortic Balloon (iab) Catheter And Accessories.
| Device ID | K122628 |
| 510k Number | K122628 |
| Device Name: | SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP., CARDIAC ASSIST DIVISION 15 LAW DR. Fairfield, NJ 07004 -0011 |
| Contact | Carla S Cerqueira |
| Correspondent | Carla S Cerqueira 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 | 2012-08-28 |
| Decision Date | 2012-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607567108612 | K122628 | 000 |
| 10607567113166 | K122628 | 000 |