E-Cath
K-Number: K152952 · 2016-07-13
ApplicantPAJUNK GmbH Medizintechnologie
Decision Date2016-07-13
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
E-Cath is a medical device manufactured by PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2016-07-13 under approval number K152952. 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 E-Cath?
E-Cath is a medical device that received FDA 510(k) clearance on 2016-07-13. It is manufactured by PAJUNK GmbH Medizintechnologie. The 510(k) number is K152952.
When was E-Cath approved by the FDA?
E-Cath received FDA 510(k) clearance on 2016-07-13, under approval number K152952.
What company makes E-Cath?
E-Cath is manufactured by PAJUNK GmbH Medizintechnologie.
What is the FDA product code for E-Cath?
The FDA product code for E-Cath 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.