PSM 3-Way Silicone Foley Catheter
K-Number: K181616 · 2018-09-21
ApplicantPathway, LLC
Decision Date2018-09-21
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
PSM 3-Way Silicone Foley Catheter is a medical device manufactured by Pathway, LLC. It received FDA 510(k) clearance on 2018-09-21 under approval number K181616. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PSM 3-Way Silicone Foley Catheter?
PSM 3-Way Silicone Foley Catheter is a medical device that received FDA 510(k) clearance on 2018-09-21. It is manufactured by Pathway, LLC. The 510(k) number is K181616.
When was PSM 3-Way Silicone Foley Catheter approved by the FDA?
PSM 3-Way Silicone Foley Catheter received FDA 510(k) clearance on 2018-09-21, under approval number K181616.
What company makes PSM 3-Way Silicone Foley Catheter?
PSM 3-Way Silicone Foley Catheter is manufactured by Pathway, LLC.
What is the FDA product code for PSM 3-Way Silicone Foley Catheter?
The FDA product code for PSM 3-Way Silicone Foley Catheter is EZL.
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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.