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FDA 510(k)

WATCHDOG Hemostasis Valve Kit

K-Number: K172453 · 2017-11-09

ApplicantBoston Scientific Corporation
Decision Date2017-11-09
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WATCHDOG Hemostasis Valve Kit 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 2017-11-09 under 510(k) number K172453. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WATCHDOG Hemostasis Valve Kit?

WATCHDOG Hemostasis Valve Kit is a medical device that received FDA 510(k) clearance on 2017-11-09. The listed applicant is Boston Scientific Corporation. The 510(k) number is K172453.

When did WATCHDOG Hemostasis Valve Kit receive FDA 510(k) clearance?

WATCHDOG Hemostasis Valve Kit received FDA 510(k) clearance on 2017-11-09, under 510(k) number K172453.

Who is the listed applicant for WATCHDOG Hemostasis Valve Kit?

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 WATCHDOG Hemostasis Valve Kit?

The FDA product code for WATCHDOG Hemostasis Valve Kit is DQX.

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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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