510(k) K120868 ยท DSP System, Balloon, Intra-Aortic And Control
MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER
| Applicant | Datascope Corp., Cardiac Assist Division, Fairfield NJ, US |
| Decision | Substantially Equivalent, Apr 20, 2012 |
| Received | Mar 22, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120868
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2023 | Datascope Corp. MEGA 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)-MEGA 7.5Fr 30cc IAB,
P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For Use: Acute Coronary Synd Open, Classified |
DSP | None listed |
| Aug 21, 2020 | Datascope Corporation Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 06 Open, Classified |
DSP | None listed |
| Aug 21, 2020 | Datascope Corporation Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10; 0684-00-0498-01, 0684-00-0498-07, 0684-0 Open, Classified |
DSP | None listed |
| Apr 16, 2018 | Datascope Corporation Intra-Aortic Balloon Catheter Mega 7.5FR 40cc
Product Usage:
The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation du Terminated |
DSP | None listed |
| Apr 16, 2018 | Datascope Corporation Intra-Aortic Balloon Catheter Mega 7.5FR 30cc
Product Usage:
The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation du Terminated |
DSP | None listed |
| May 13, 2016 | Datascope Corporation MEGA 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK
MEGA 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK
MEGA 8Fr. 50cc Intra-Aortic Balloon Cathete Terminated |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.