FDA 510(k)

WATCHMAN TruSteer Access System (M635TU90050)

K-Number: K240018 · 2024-02-01

Decision Date2024-02-01

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

WATCHMAN TruSteer Access System (M635TU90050) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2024-02-01 under 510(k) number K240018. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WATCHMAN TruSteer Access System (M635TU90050)?

WATCHMAN TruSteer Access System (M635TU90050) is a medical device that received FDA 510(k) clearance on 2024-02-01. The listed applicant is Boston Scientific Corporation. The 510(k) number is K240018.

When did WATCHMAN TruSteer Access System (M635TU90050) receive FDA 510(k) clearance?

WATCHMAN TruSteer Access System (M635TU90050) received FDA 510(k) clearance on 2024-02-01, under 510(k) number K240018.

Who is the listed applicant for WATCHMAN TruSteer Access System (M635TU90050)?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WATCHMAN TruSteer Access System (M635TU90050)?

The FDA product code for WATCHMAN TruSteer Access System (M635TU90050) is DQY.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.