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FDA 510(k)

Acute Dual Lumen Hemodialysis Catheter

K-Number: K200426 · 2020-12-24

ApplicantHealth Line International Corporation
Decision Date2020-12-24
Product CodeMPB
Advisory CommitteeGU
DecisionUnknown

Device Summary

Acute Dual Lumen Hemodialysis Catheter is a medical device manufactured by Health Line International Corporation. It received FDA 510(k) clearance on 2020-12-24 under approval number K200426. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Acute Dual Lumen Hemodialysis Catheter?

Acute Dual Lumen Hemodialysis Catheter is a medical device that received FDA 510(k) clearance on 2020-12-24. It is manufactured by Health Line International Corporation. The 510(k) number is K200426.

When was Acute Dual Lumen Hemodialysis Catheter approved by the FDA?

Acute Dual Lumen Hemodialysis Catheter received FDA 510(k) clearance on 2020-12-24, under approval number K200426.

What company makes Acute Dual Lumen Hemodialysis Catheter?

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

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

The FDA product code for Acute Dual Lumen Hemodialysis Catheter is MPB.

Related Clinical Trials

NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) 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 NCT05372679 REDUCED 1 - Renal Denervation Using Ultrasonic Catheter EmitteD Energy Study / ACTIVE_NOT_RECRUITING NCT06808217 A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation ACTIVE_NOT_RECRUITING

Other Devices by Health Line International Corporation

K160448ARTLINE K192533Health Line CT CVC K200263Health Line CT Midline Catheter K222170Power Acute Triple Lumen Hemodialysis Catheter

Related Devices (Code: MPB)

K153190Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc. K163458Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc. K161504Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook Incorporated K192807Duo-Flow Side x Side Double Lumen CatheterMedical Components, Inc. (dba MedComp) K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterCovidien, LLC K25083614F Duo-Flow® Side X Side Double Lumen CatheterMedical Components, Inc.

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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