# P980037: Angiojet Rheolytic Thrombectomy LF140 Catheter

- Pathway: PMA
- Applicant: Boston Scientific Corp
- Decided: Mar 12, 1999 after 179 days
- Product code: MCX (Catheter, Coronary, Atherectomy)
- Device class: 3
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Nov 8, 2019 · Class II · Z-0717-2020: Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.
- Jan 31, 2017 · Class II · Z-1401-2017: Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot switch sticking during use resulting in an undesired continued operation of the device.

Source page: https://510kreport.com/device/P980037
Methodology: https://510kreport.com/methodology