# K180864: WATCHMAN TruSeal Access System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Jul 20, 2018 after 109 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 5 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K893658 (1989). 40 ancestors in all.
2 later devices descend 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)
- K083214: Amplatzer Torqvue  45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100, 9-TV45X45-10F-100, Aga Medical Corp. (2009) Summary page 4.

## Most influential descendants
- K212228: WATCHMAN FXD Curve Access System (2021), 1 descendant of its own
- K240018: WATCHMAN TruSteer Access System (M635TU90050) (2024), 0 descendants of its own

## Recalls of this device
- Jul 29, 2025 · Class I · Z-2426-2025: 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-2431-2025: 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-2432-2025: 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-2428-2025: 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-2427-2025: 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™ TruSeal™ Access System is intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.

Source page: https://510kreport.com/device/K180864
Methodology: https://510kreport.com/methodology