Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CAREline Airless Hemodialysis Blood Tubing Sets

K-Number: K172238 · 2017-12-14

ApplicantFresenius Medical Care Renal Therapies Group, LLC
Decision Date2017-12-14
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CAREline Airless Hemodialysis Blood Tubing Sets is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2017-12-14 under approval number K172238. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAREline Airless Hemodialysis Blood Tubing Sets?

CAREline Airless Hemodialysis Blood Tubing Sets is a medical device that received FDA 510(k) clearance on 2017-12-14. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K172238.

When was CAREline Airless Hemodialysis Blood Tubing Sets approved by the FDA?

CAREline Airless Hemodialysis Blood Tubing Sets received FDA 510(k) clearance on 2017-12-14, under approval number K172238.

What company makes CAREline Airless Hemodialysis Blood Tubing Sets?

CAREline Airless Hemodialysis Blood Tubing Sets is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.

What is the FDA product code for CAREline Airless Hemodialysis Blood Tubing Sets?

The FDA product code for CAREline Airless Hemodialysis Blood Tubing Sets is KOC.

Related Clinical Trials

NCT04956120 Effect of Citrate Dialysate on Vascular Calcification COMPLETED NCT06032208 An Extension to Assess the Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL RECRUITING NCT06340269 Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in ACLF COMPLETED NCT07538310 Laser Acupuncture for Fatigue in Hemodialysis Patients NOT_YET_RECRUITING NCT05588011 Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass COMPLETED

Other Devices by Fresenius Medical Care Renal Therapies Group, LLC

K1534492008K2 Hemodialysis Machine K160749CRIT-LINE III Blood Chamber II K171652Fresenius Liberty Select Cycler K162716bibag K181108Fresenius Liberty Select Cycler K173593stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch

View all 47 devices →

Related Devices (Code: KOC)

K160749CRIT-LINE III Blood Chamber IIFresenius Medical Care Renal Therapies Group, LLC K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin LineFresenius Medical Care Renal Therapies Group, LLC K231589Blood Tubing Lines for Hemodialysis AV06C-ENIKKISO CO., LTD. K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 SeriesNIKKISO CO., LTD. K242479BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PUNIKKISO CO., LTD. K242176BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)NIKKISO CO., LTD.

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.

↑