# K212228: WATCHMAN FXD Curve Access System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Aug 13, 2021 after 28 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 3 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K893658 (1989). 41 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180864: WATCHMAN TruSeal Access System, Boston Scientific (2018) Summary page 4.

## Most influential descendants
- K240018: WATCHMAN TruSteer Access System (M635TU90050) (2024), 0 descendants of its own

## Recalls of this device
- Jul 29, 2025 · Class I · Z-2434-2025: 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
- Jul 29, 2025 · Class I · Z-2429-2025: 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
- Jul 29, 2025 · Class I · Z-2435-2025: 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 FXD Curve Access System is intended to provide vascular and transseptal access for the WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System.

Source page: https://510kreport.com/device/K212228
Methodology: https://510kreport.com/methodology