Company
Maquet Datascope Corp - Cardiac Assist Division
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
15recalls (0 in 12 months)
15recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2018 | Maquet Datascope Corp - Cardiac Assist Division Cardiosave Rescue IABP, Part Number 0998-UC-0800-83 Open, Classified |
DSP | K181122 |
| Oct 27, 2018 | Maquet Datascope Corp - Cardiac Assist Division Cardiosave Hybrid IABP, Part Number 0998-00-0800-53 Open, Classified |
DSP | K181122 |
| May 3, 2018 | Maquet Datascope Corp - Cardiac Assist Division CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179 Open, Classified |
DSP | K112372 K151254 |
| Jul 17, 2017 | Maquet Datascope Corp - Cardiac Assist Division CS 300 Intra-Aortic Balloon Pump.
It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pre Open, Classified |
DSP | K151254 |
| Jul 17, 2017 | Maquet Datascope Corp - Cardiac Assist Division CS 100 Intra-Aortic Balloon Pump.
It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pre Open, Classified |
DSP | K031636 |
| Jul 17, 2017 | Maquet Datascope Corp - Cardiac Assist Division CS 100i Intra-Aortic Balloon Pump.
It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pr Open, Classified |
DSP | K031636 |
| Jun 23, 2017 | Maquet Datascope Corp - Cardiac Assist Division CS 300 Intra-Aortic Balloon Pump Terminated |
DSP | K151254 |
| Jun 23, 2017 | Maquet Datascope Corp - Cardiac Assist Division CS 100 Intra-Aortic Balloon Pump Terminated |
DSP | K031636 |
| Jun 23, 2017 | Maquet Datascope Corp - Cardiac Assist Division CS 100i Intra-Aortic Balloon Pump Terminated |
DSP | K031636 |
| Dec 23, 2016 | Maquet Datascope Corp - Cardiac Assist Division CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX
Li-Ion Battery affected part number is 0146-00-0097
Product Usage:
The CARDIOSAVE Hybrid Intra-Aortic Ball Terminated |
DSP | K112372 K151254 |
| Dec 16, 2015 | Maquet Datascope Corp - Cardiac Assist Division Cardiosave Hybrid and rescue IABP Terminated |
DSP | K112372 |
| Feb 23, 2015 | Maquet Datascope Corp - Cardiac Assist Division Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) Terminated |
DSP | K112372 |
| 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 | K063525 K112372 |
| 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 | K031636 K063525 +1 |
| 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 | K031636 K063525 +1 |