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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 a medical device manufactured by Health Line International Corporation. It received FDA 510(k) clearance on 2023-01-13 under approval 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. It is manufactured by Health Line International Corporation. The 510(k) number is K222170.

When was Power Acute Triple Lumen Hemodialysis Catheter approved by the FDA?

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

What company makes Power Acute Triple Lumen Hemodialysis Catheter?

Power Acute Triple Lumen Hemodialysis Catheter is manufactured by Health Line International Corporation.

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

NCT07601763 Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT06968026 Right Prefrontal Autonomic Mapping in Recurrent Pregnancy Loss With Comorbid Anxiety RECRUITING NCT07216170 REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke NOT_YET_RECRUITING NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED

Other Devices by Health Line International Corporation

K160448ARTLINE K192533Health Line CT CVC K200426Acute Dual Lumen Hemodialysis Catheter K200263Health Line CT Midline Catheter

Related Devices (Code: NIE)

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