510(k) K112327 ยท DSP System, Balloon, Intra-Aortic And Control
SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
| Applicant | Cardiac Assist, Maquet Cardiovascular, LLC, Manwah NJ, US |
| Decision | Substantially Equivalent, Sep 9, 2011 |
| Received | Aug 12, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112327
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2024 | Datascope Corp. MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00-
0295-01 Open, Classified |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.