Class Class II

14F Duo-Flow® Side X Side Double Lumen Catheter (K250836)

K250836 2025-08-12 Traditional
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Description

14F Duo-Flow® Side X Side Double Lumen Catheter by Medical Components, Inc., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250836
Clearance Date2025-08-12
Clearance TypeTraditional
Product CodeMPB
Regulation Number876.5540

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Predicate lineage for K250836

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. 14F Duo-Flow® Side X Side Double Lumen Catheter (K250836) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K192807Duo-Flow Side x Side Double Lumen CatheterMedical Components, Inc. (dba MedComp)2020

Trace the full predicate network for K250836

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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