# K120868: Mega (TM) 7.5FR. 30CC Intra-Aortic Balloon Catheter and Accessories, Mega (TM) 7.5FR. 40CC Intra-Aortic Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Datascope Corp., Cardiac Assist Division
- Decided: Apr 20, 2012 after 29 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K122628: Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and Accessories (2012), 0 descendants of its own

## Recalls of this device
- Jun 23, 2023 · Class II · Z-2219-2023: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery
- Jul 27, 2020 · Class II · Z-2832-2020: Potential Endotoxin Contamination
- Jul 27, 2020 · Class II · Z-2831-2020: Potential Endotoxin Contamination
- Jul 27, 2020 · Class II · Z-2833-2020: Potential Endotoxin Contamination
- Feb 21, 2018 · Class II · Z-1384-2018: The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
- Feb 21, 2018 · Class II · Z-1383-2018: The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
- May 13, 2016 · Class II · Z-1935-2016: It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously p

Source page: https://510kreport.com/device/K120868
Methodology: https://510kreport.com/methodology