510(k) K041281 ยท DSP System, Balloon, Intra-Aortic And Control
DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
| Applicant | Datascope Corp., Fairfield NJ, US |
| Decision | Substantially Equivalent, Jun 7, 2004 |
| Received | May 13, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041281
| 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 |
| Jul 21, 2023 | Datascope Corp. LINEAR 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 |
| Oct 24, 2022 | Datascope Corporation LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter. Open, Classified |
DSQ | None listed |
| Aug 21, 2020 | Datascope Corporation Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit
P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U
0684-00-0478-02, 0684-00-0478-02U - Product Usage: Indications For Open, Classified |
DSP | None listed |
| Aug 21, 2020 | Datascope Corporation Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08, Open, Classified |
DSP | None listed |
| Aug 21, 2020 | Datascope Corporation Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB
Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07, Open, Classified |
DSP | None listed |
| Sep 3, 2014 | Datascope Corporation LINEAR 7.5 FR. 40cc IAB Catheter
Maquet Getinge Group Terminated |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.