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FDA 510(k)

90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET

K-Number: K903869 · 1990-11-20

ApplicantFresenius/Delmed, Inc.
Decision Date1990-11-20
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius/Delmed, Inc.. It received FDA 510(k) clearance on 1990-11-20 under 510(k) number K903869. 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 90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET?

90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET is a medical device that received FDA 510(k) clearance on 1990-11-20. The listed applicant is Fresenius/Delmed, Inc.. The 510(k) number is K903869.

When did 90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET receive FDA 510(k) clearance?

90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET received FDA 510(k) clearance on 1990-11-20, under 510(k) number K903869.

Who is the listed applicant for 90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET?

The FDA 510(k) record lists Fresenius/Delmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET?

The FDA product code for 90/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET 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

Other records listing Fresenius/Delmed, Inc. as applicant

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.

K902149FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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