510(k) K122628 ยท DSP System, Balloon, Intra-Aortic And Control
SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES
| Applicant | Datascope Corp., Cardiac Assist Division, Fairfield NJ, US |
| Decision | Substantially Equivalent, Sep 6, 2012 |
| Received | Aug 28, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122628
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2023 | Datascope Corp. SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta
Product Description Open, Classified |
DSP | None listed |
| Aug 21, 2020 | Datascope Corporation Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09
- Product Usage: Indications For Use: Acute Open, Classified |
DSP | None listed |
| May 28, 2019 | Datascope Corporation Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01
Product Usage:
The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is Terminated |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.