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FDA 510(k)

WATCHMAN TruSeal Access System

K-Number: K180864 · 2018-07-20

ApplicantBoston Scientific
Decision Date2018-07-20
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WATCHMAN TruSeal Access System is a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2018-07-20 under approval number K180864. 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 TruSeal Access System?

WATCHMAN TruSeal Access System is a medical device that received FDA 510(k) clearance on 2018-07-20. It is manufactured by Boston Scientific. The 510(k) number is K180864.

When was WATCHMAN TruSeal Access System approved by the FDA?

WATCHMAN TruSeal Access System received FDA 510(k) clearance on 2018-07-20, under approval number K180864.

What company makes WATCHMAN TruSeal Access System?

WATCHMAN TruSeal Access System is manufactured by Boston Scientific.

What is the FDA product code for WATCHMAN TruSeal Access System?

The FDA product code for WATCHMAN TruSeal Access System is DQY.

Related Clinical Trials

NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT07262255 WATCHMAN FLX Pro European Registry RECRUITING NCT05934487 PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III RECRUITING NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED NCT05501873 Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System ACTIVE_NOT_RECRUITING

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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Related Devices (Code: DQY)

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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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