# K240018: WATCHMAN TruSteer Access System (M635TU90050)

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Feb 1, 2024 after 30 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K893658 (1989). 42 ancestors in all.
No later device cites it as a predicate yet.
3 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212228: WATCHMAN FXD Curve Access System, Boston Scientific Corporation (2021) Summary page 5.

## Recalls of this device
- Jul 29, 2025 · Class I · Z-2436-2025: Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinic

## Indications for use
The WATCHMAN TruSteer Access System is intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

Source page: https://510kreport.com/device/K240018
Methodology: https://510kreport.com/methodology