Certa Catheter
K-Number: K171193 · 2017-12-18
ApplicantFerrosan Medical Devices Sp. Z.O.O.
Decision Date2017-12-18
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Certa Catheter is a medical device manufactured by Ferrosan Medical Devices Sp. Z.O.O.. It received FDA 510(k) clearance on 2017-12-18 under approval number K171193. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Certa Catheter?
Certa Catheter is a medical device that received FDA 510(k) clearance on 2017-12-18. It is manufactured by Ferrosan Medical Devices Sp. Z.O.O.. The 510(k) number is K171193.
When was Certa Catheter approved by the FDA?
Certa Catheter received FDA 510(k) clearance on 2017-12-18, under approval number K171193.
What company makes Certa Catheter?
Certa Catheter is manufactured by Ferrosan Medical Devices Sp. Z.O.O..
What is the FDA product code for Certa Catheter?
The FDA product code for Certa Catheter is BSO.
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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.