Decision Date2017-11-17
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Langston dual lumen catheter is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2017-11-17 under 510(k) number K170544. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Langston dual lumen catheter?
Langston dual lumen catheter is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K170544.
When did Langston dual lumen catheter receive FDA 510(k) clearance?
Langston dual lumen catheter received FDA 510(k) clearance on 2017-11-17, under 510(k) number K170544.
Who is the listed applicant for Langston dual lumen catheter?
The FDA 510(k) record lists Vascular Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Langston dual lumen catheter?
The FDA product code for Langston dual lumen catheter is DQO.
Other records listing Vascular Solutions, Inc. as applicant
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Related Devices (Code: DQO)
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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.