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FDA 510(k)

Power Acute Triple Lumen Hemodialysis Catheter

K-Number: K222170 · 2023-01-13

ApplicantHealth Line International Corporation
Decision Date2023-01-13
Product CodeNIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Power Acute Triple Lumen Hemodialysis Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Health Line International Corporation. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K222170. The device is classified under product code NIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Power Acute Triple Lumen Hemodialysis Catheter?

Power Acute Triple Lumen Hemodialysis Catheter is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Health Line International Corporation. The 510(k) number is K222170.

When did Power Acute Triple Lumen Hemodialysis Catheter receive FDA 510(k) clearance?

Power Acute Triple Lumen Hemodialysis Catheter received FDA 510(k) clearance on 2023-01-13, under 510(k) number K222170.

Who is the listed applicant for Power Acute Triple Lumen Hemodialysis Catheter?

The FDA 510(k) record lists Health Line International Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Power Acute Triple Lumen Hemodialysis Catheter?

The FDA product code for Power Acute Triple Lumen Hemodialysis Catheter is NIE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07585188Neonatal Catheter Lock for Infection PreventionNOT_YET_RECRUITING

Other records listing Health Line International Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261950Health Line Tearaway IntroducerK200426Acute Dual Lumen Hemodialysis CatheterK200263Health Line CT Midline CatheterK192533Health Line CT CVCK160448ARTLINE

Related Devices (Code: NIE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp)K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)K18117512F Tri-Flow Triple Lumen CatheterMedical Components, Inc. (dba MedComp)

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.

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