The following data is part of a premarket notification filed by Datascope Corp., Cardiac Assist Division with the FDA for Mega(tm) 7.5fr. 30cc Intra-aortic Balloon Catheter And Accessories, Mega(tm) 7.5fr. 40cc Intra-aortic Balloon Catheter.
| Device ID | K120868 |
| 510k Number | K120868 |
| Device Name: | MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP., CARDIAC ASSIST DIVISION 15 LAW DR. Fairfield, NJ 07004 -0011 |
| Contact | Helder A Sousa |
| Correspondent | Helder A Sousa 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 | 2012-03-22 |
| Decision Date | 2012-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607567108025 | K120868 | 000 |