SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES— 510(k) K122628
Substantially EquivalentDatascope Corp., Cardiac Assist Division
FDA 510(k) clearance K122628 for SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES, Substantially Equivalent on 2012-09-06. Applicant: Datascope Corp., Cardiac Assist Division. Device class: 2.
Clearance details
- Applicant
- Datascope Corp., Cardiac Assist Division
- Product code
- Code DSP
- Device class
- Class 2
- Regulation
- 21 CFR 870.3535
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Fairfield, NJ, US
Recent devices under product code DSP
view allMore clearances from Datascope Corp., Cardiac Assist Division
view allAdverse events under product code DSP
product code DSP- Death
- 317
- Injury
- 566
- Malfunction
- 36,831
- Other
- 4
- Total
- 37,718
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K122628
K-number listed on FDA's recall record- Z-2221-2023 — SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES D684-00-0568-01 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (W/O STATLOCK) D684-00-0568-03 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (WITH PRESSURE D684-00-0568-05 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (TURKEY) D684-00-0568-09 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES, US ONLY D684-00-0568-01U PACKAGED INSERTION KIT - SENSATION PLUS 7.5 Fr. 40 cc IAB D884-00-0019-22
- Z-2836-2020 — Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
- Z-1966-2019 — Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stabilization devices. It is a cardiac assist device intended to provide counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122628.
Data sourced from openFDA. This site is unofficial and independent of the FDA.