Turbo-Flo PICC Sets
K-Number: K161496 · 2016-10-07
ApplicantCook Incorporated
Decision Date2016-10-07
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Turbo-Flo PICC Sets is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2016-10-07 under approval number K161496. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Turbo-Flo PICC Sets?
Turbo-Flo PICC Sets is a medical device that received FDA 510(k) clearance on 2016-10-07. It is manufactured by Cook Incorporated. The 510(k) number is K161496.
When was Turbo-Flo PICC Sets approved by the FDA?
Turbo-Flo PICC Sets received FDA 510(k) clearance on 2016-10-07, under approval number K161496.
What company makes Turbo-Flo PICC Sets?
Turbo-Flo PICC Sets is manufactured by Cook Incorporated.
What is the FDA product code for Turbo-Flo PICC Sets?
The FDA product code for Turbo-Flo PICC Sets is LJS.
Other Devices by Cook Incorporated
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K153469Cathtong I PICC CatheterL&Z Us, Inc.
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K152819Amecath Peripheral inserted Central Venous Catheter SetsAmeco Medical Industries
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.