Decision Date2020-05-01
Product CodeMQF
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Kitazato ET Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2020-05-01 under 510(k) number K192540. The device is classified under product code MQF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Kitazato ET Catheters?
Kitazato ET Catheters is a medical device that received FDA 510(k) clearance on 2020-05-01. The listed applicant is Kitazato Corporation. The 510(k) number is K192540.
When did Kitazato ET Catheters receive FDA 510(k) clearance?
Kitazato ET Catheters received FDA 510(k) clearance on 2020-05-01, under 510(k) number K192540.
Who is the listed applicant for Kitazato ET Catheters?
The FDA 510(k) record lists Kitazato Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Kitazato ET Catheters?
The FDA product code for Kitazato ET Catheters is MQF.
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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.