Atlas FDA

WATCHMAN FXD Curve Access System

FDA 510(k) clearance K212228 · decided 2021-08-13

Clearance details

K-number
K212228
Device name
WATCHMAN FXD Curve Access System
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2021-07-16
Decision date
2021-08-13
Days to decision
28 days
Clearance type
Special
Product code
DQY
Device class
2
Regulation number
870.1250
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Maple Grove, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to pro recall (Z-2429-2025)Boston Scientific Corporation2025-08-29
WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to p recall (Z-2434-2025)Boston Scientific Corporation2025-08-29
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to p recall (Z-2435-2025)Boston Scientific Corporation2025-08-29

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