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FDA 510(k)

WATCHMAN FXD Curve Access System

K-Number: K212228 · 2021-08-13

ApplicantBoston Scientific Corporation
Decision Date2021-08-13
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WATCHMAN FXD Curve Access System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2021-08-13 under approval number K212228. 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 FXD Curve Access System?

WATCHMAN FXD Curve Access System is a medical device that received FDA 510(k) clearance on 2021-08-13. It is manufactured by Boston Scientific Corporation. The 510(k) number is K212228.

When was WATCHMAN FXD Curve Access System approved by the FDA?

WATCHMAN FXD Curve Access System received FDA 510(k) clearance on 2021-08-13, under approval number K212228.

What company makes WATCHMAN FXD Curve Access System?

WATCHMAN FXD Curve Access System is manufactured by Boston Scientific Corporation.

What is the FDA product code for WATCHMAN FXD Curve Access System?

The FDA product code for WATCHMAN FXD Curve Access System is DQY.

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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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