Class Class II

Power Acute Triple Lumen Hemodialysis Catheter (K222170)

K222170 2023-01-13 Traditional
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Description

Power Acute Triple Lumen Hemodialysis Catheter by Health Line International Corporation, an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK222170
Clearance Date2023-01-13
Clearance TypeTraditional
Product CodeNIE
Regulation Number876.5540

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Predicate lineage for K222170

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. Power Acute Triple Lumen Hemodialysis Catheter (K222170) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K141531POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETERC.R. Bard, Inc.2015
K102605MAHURKAR TRIPLE LUMEN DIALYSIS CATHETERCovidien, LLC, Formerly Registered ...2010

Trace the full predicate network for K222170

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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