SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES
FDA 510(k) clearance K122628 · decided 2012-09-06
Clearance details
- K-number
- K122628
- Device name
- SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES
- Applicant
- Datascope Corp., Cardiac Assist Division
- Decision
- Substantially Equivalent
- Date received
- 2012-08-28
- Decision date
- 2012-09-06
- Days to decision
- 9 days
- Clearance type
- Special
- Product code
- DSP
- Device class
- 2
- Regulation number
- 870.3535
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fairfield, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide c recall (Z-2221-2023) | Datascope Corp. | 2023-07-21 |
| Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 068 recall (Z-2836-2020) | Datascope Corporation | 2020-08-21 |