Cleared Special

WATCHMAN TruSteer Access System (M635TU90050)

K240018 · Boston Scientific Corporation · Cardiovascular
Feb 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K240018 is an FDA 510(k) clearance for the WATCHMAN TruSteer Access System (M635TU90050), a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Boston Scientific Corporation (Malborough, US). The FDA issued a Cleared decision on February 1, 2024, 30 days after receiving the submission on January 2, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K240018 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2024
Decision Date February 01, 2024
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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