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)

CRIT-LINE III Blood Chamber II

K-Number: K160749 · 2016-04-15

ApplicantFresenius Medical Care Renal Therapies Group, LLC
Decision Date2016-04-15
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CRIT-LINE III Blood Chamber II is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2016-04-15 under approval number K160749. 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 CRIT-LINE III Blood Chamber II?

CRIT-LINE III Blood Chamber II is a medical device that received FDA 510(k) clearance on 2016-04-15. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K160749.

When was CRIT-LINE III Blood Chamber II approved by the FDA?

CRIT-LINE III Blood Chamber II received FDA 510(k) clearance on 2016-04-15, under approval number K160749.

What company makes CRIT-LINE III Blood Chamber II?

CRIT-LINE III Blood Chamber II is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.

What is the FDA product code for CRIT-LINE III Blood Chamber II?

The FDA product code for CRIT-LINE III Blood Chamber II is KOC.

Related Clinical Trials

NCT06059638 BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT RECRUITING NCT07598760 Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction NOT_YET_RECRUITING NCT07589452 Impact of Allometric Pacing Rate on Ventricular Diastolic Function and Cerebral Blood Flow in Hypertensive Patients With Sinus Node Dysfunction NOT_YET_RECRUITING NCT07585227 Study of the Effects of Acute Exposure to Moderate Altitude Hypoxia on Prospective Memory. NOT_YET_RECRUITING NCT07515716 Effects of High Flow Humidified Oxygen on Umbilical Artery Acid-base Balance in Cesarean Section Under Spinal Anesthesia NOT_YET_RECRUITING

Other Devices by Fresenius Medical Care Renal Therapies Group, LLC

K1534492008K2 Hemodialysis Machine K172238CAREline Airless Hemodialysis Blood Tubing Sets 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)

K172238CAREline Airless Hemodialysis Blood Tubing SetsFresenius 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.

↑