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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 the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2018-07-20 under 510(k) 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. The listed applicant is Boston Scientific. The 510(k) number is K180864.

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

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

Who is the listed applicant for WATCHMAN TruSeal Access System?

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

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

The FDA product code for WATCHMAN TruSeal Access System is 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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