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FDA 510(k)

WATCHMAN TruSteer Access System (M635TU90050)

K-Number: K240018 · 2024-02-01

ApplicantBoston Scientific Corporation
Decision Date2024-02-01
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WATCHMAN TruSteer Access System (M635TU90050) is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2024-02-01 under approval 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. It is manufactured by Boston Scientific Corporation. The 510(k) number is K240018.

When was WATCHMAN TruSteer Access System (M635TU90050) approved by the FDA?

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

What company makes WATCHMAN TruSteer Access System (M635TU90050)?

WATCHMAN TruSteer Access System (M635TU90050) is manufactured by Boston Scientific Corporation.

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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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

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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.

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