Park Blade Septostomy Catheter
K-Number: K182399 · 2019-04-04
ApplicantCook Incorporated
Decision Date2019-04-04
Product CodeDXF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Park Blade Septostomy Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2019-04-04 under approval number K182399. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Park Blade Septostomy Catheter?
Park Blade Septostomy Catheter is a medical device that received FDA 510(k) clearance on 2019-04-04. It is manufactured by Cook Incorporated. The 510(k) number is K182399.
When was Park Blade Septostomy Catheter approved by the FDA?
Park Blade Septostomy Catheter received FDA 510(k) clearance on 2019-04-04, under approval number K182399.
What company makes Park Blade Septostomy Catheter?
Park Blade Septostomy Catheter is manufactured by Cook Incorporated.
What is the FDA product code for Park Blade Septostomy Catheter?
The FDA product code for Park Blade Septostomy Catheter is DXF.
Other Devices by Cook Incorporated
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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.