SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
FDA 510(k) clearance K112327 · decided 2011-09-09
Clearance details
- K-number
- K112327
- Device name
- SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
- Applicant
- Cardiac Assist, Maquet Cardiovascular, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-08-12
- Decision date
- 2011-09-09
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- DSP
- Device class
- 2
- Regulation number
- 870.3535
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Manwah, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01 recall (Z-0311-2025) | Datascope Corp. | 2024-11-05 |