510(k) K133074 ยท DSP System, Balloon, Intra-Aortic And Control
MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
| Applicant | Datascope Corp., Fairfield NJ, US |
| Decision | Substantially Equivalent, Dec 12, 2013 |
| Received | Sep 30, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133074
| 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. MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta
Product Description Open, Classified |
DSP | None listed |
| Jul 21, 2023 | Datascope Corp. SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta
Product Description Open, Classified |
DSP | None listed |
| Sep 8, 2022 | Datascope Corporation MEGA 8Fr 50cc Intra-Aortic Balloon Catheter Open, Classified |
DSP | None listed |
| Sep 8, 2022 | Datascope Corporation Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter Open, Classified |
DSP | None listed |
| Sep 8, 2022 | Datascope Corporation Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter Open, Classified |
DSP | None listed |
| Aug 21, 2020 | Datascope Corporation Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-09 - Product Usage: Indications For Use: Acute Cor Open, Classified |
DSP | None listed |
| Apr 16, 2018 | Datascope Corporation Intra-Aortic Balloon Catheter Mega 8FR 50cc
Product Usage:
The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation durin Terminated |
DSP | None listed |
| Apr 12, 2017 | Datascope Corporation SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by Terminated |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.