High-Flo Silver Polyethylene Catheter
K-Number: K172635 · 2018-04-03
ApplicantCook Incorporated
Decision Date2018-04-03
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
High-Flo Silver Polyethylene Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-04-03 under approval number K172635. 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 High-Flo Silver Polyethylene Catheter?
High-Flo Silver Polyethylene Catheter is a medical device that received FDA 510(k) clearance on 2018-04-03. It is manufactured by Cook Incorporated. The 510(k) number is K172635.
When was High-Flo Silver Polyethylene Catheter approved by the FDA?
High-Flo Silver Polyethylene Catheter received FDA 510(k) clearance on 2018-04-03, under approval number K172635.
What company makes High-Flo Silver Polyethylene Catheter?
High-Flo Silver Polyethylene Catheter is manufactured by Cook Incorporated.
What is the FDA product code for High-Flo Silver Polyethylene Catheter?
The FDA product code for High-Flo Silver Polyethylene Catheter is 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.