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FDA 510(k)

APD LUER-LOCK ADAPTER

K-Number: K124024 · 2013-09-19

ApplicantFresensius Medical Care North America
Decision Date2013-09-19
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

APD LUER-LOCK ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Fresensius Medical Care North America. It received FDA 510(k) clearance on 2013-09-19 under 510(k) number K124024. 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 APD LUER-LOCK ADAPTER?

APD LUER-LOCK ADAPTER is a medical device that received FDA 510(k) clearance on 2013-09-19. The listed applicant is Fresensius Medical Care North America. The 510(k) number is K124024.

When did APD LUER-LOCK ADAPTER receive FDA 510(k) clearance?

APD LUER-LOCK ADAPTER received FDA 510(k) clearance on 2013-09-19, under 510(k) number K124024.

Who is the listed applicant for APD LUER-LOCK ADAPTER?

The FDA 510(k) record lists Fresensius Medical Care North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APD LUER-LOCK ADAPTER?

The FDA product code for APD LUER-LOCK ADAPTER is KDJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: KDJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250404stay•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, LLCK231849MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483Baxter HealthcareK21401615L Cycler Drainage BagBaxter Healthcare CorporationK192705MiniCap Extended Life PD Transfer SetsBaxter HealthcareK173593stay•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, LLCK173651Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetFresenius Medical Care Renal Therapies Group, LLC

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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