510(k) K063525 ยท DSP System, Balloon, Intra-Aortic And Control
DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
| Applicant | Datascope Corp., Fairfield NJ, US |
| Decision | Substantially Equivalent, Jan 5, 2007 |
| Received | Nov 22, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063525
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2026 | Datascope Corp. CS300 IABP. Software Version CS300 IABP C.01. Open, Classified |
DSP | None listed |
| Jul 21, 2023 | Datascope Corp. SENSATION 7 Fr. 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 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09.
Product Usage: Indications For Open, Classified |
DSP | None listed |
| Aug 21, 2020 | Datascope Corporation Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, 0684-00-0470-09 - Product Usage: Indications For Use: Acute Coronary Open, Classified |
DSP | None listed |
| Feb 7, 2015 | Maquet Datascope Corp - Cardiac Assist Division CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998 Terminated |
DSP | None listed |
| May 21, 2014 | Maquet Datascope Corp - Cardiac Assist Division Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons Terminated |
DSP | None listed |
| Jun 13, 2011 | Maquet Datascope Corp - Cardiac Assist Division Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump;
Manufactured by Datascope Corp., 1300 MacArthur Blvd., M Terminated |
FMZ | None listed |
| Jun 21, 2010 | Datascope Corporation CS300 Intra-Aortic Balloon Pump Terminated |
DSP | None listed |
| Apr 15, 2009 | Datascope Corporation Low-Level Output Cable.
The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor. Terminated |
DSP | None listed |
| Jan 31, 2008 | Datascope Corp Datascope CS 100 Intra-Aortic Balloon Pump and Datascope
CS 300 Intra-Aortic Balloon Pump, Datascope Corp. Mahwah, NJ 07430 Terminated |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.