The following data is part of a premarket notification filed by Cardiac Assist, Maquet Cardiovascular Llc with the FDA for Sensation(tm) Plus 8fr. 50cc Intra-aortic Balloon Catheter And Accessories.
| Device ID | K112327 |
| 510k Number | K112327 |
| Device Name: | SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC 1300 MACARTHUR BLVD Mahwah, NJ 07430 |
| Contact | Helder A Sousa |
| Correspondent | Helder A Sousa CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC 1300 MACARTHUR BLVD Mahwah, NJ 07430 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-12 |
| Decision Date | 2011-09-09 |
| Summary: | summary |