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)

Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set

K-Number: K173651 · 2018-02-14

ApplicantFresenius Medical Care Renal Therapies Group, LLC
Decision Date2018-02-14
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2018-02-14 under approval number K173651. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set?

Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set is a medical device that received FDA 510(k) clearance on 2018-02-14. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K173651.

When was Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set approved by the FDA?

Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set received FDA 510(k) clearance on 2018-02-14, under approval number K173651.

What company makes Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set?

Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.

What is the FDA product code for Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set?

The FDA product code for Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set is KDJ.

Related Clinical Trials

NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING

Other Devices by Fresenius Medical Care Renal Therapies Group, LLC

K1534492008K2 Hemodialysis Machine K160749CRIT-LINE III Blood Chamber II K172238CAREline Airless Hemodialysis Blood Tubing Sets K171652Fresenius Liberty Select Cycler K162716bibag K181108Fresenius Liberty Select Cycler

View all 47 devices →

Related Devices (Code: KDJ)

K151620Firefly Peritoneal Dialysis Connector Disinfection SystemPuracath Medical, Inc. 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 inchFresenius Medical Care Renal Therapies Group, LLC K173363Cycler Drain Bag SetFresenius Medical Care Renal Therapies Group, LLC K192705MiniCap Extended Life PD Transfer SetsBaxter Healthcare K21401615L Cycler Drainage BagBaxter Healthcare Corporation K231849MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483Baxter Healthcare

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.

↑