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FDA 510(k)

CAPD DISPOSABLE Y SYSTEM - DY SET

K-Number: K883393 · 1988-11-03

ApplicantMedionics International , Ltd.
Decision Date1988-11-03
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CAPD DISPOSABLE Y SYSTEM - DY SET is the device name listed in this FDA 510(k) record. The listed applicant is Medionics International , Ltd.. It received FDA 510(k) clearance on 1988-11-03 under 510(k) number K883393. 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 CAPD DISPOSABLE Y SYSTEM - DY SET?

CAPD DISPOSABLE Y SYSTEM - DY SET is a medical device that received FDA 510(k) clearance on 1988-11-03. The listed applicant is Medionics International , Ltd.. The 510(k) number is K883393.

When did CAPD DISPOSABLE Y SYSTEM - DY SET receive FDA 510(k) clearance?

CAPD DISPOSABLE Y SYSTEM - DY SET received FDA 510(k) clearance on 1988-11-03, under 510(k) number K883393.

Who is the listed applicant for CAPD DISPOSABLE Y SYSTEM - DY SET?

The FDA 510(k) record lists Medionics International , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPD DISPOSABLE Y SYSTEM - DY SET?

The FDA product code for CAPD DISPOSABLE Y SYSTEM - DY 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.

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Other records listing Medionics International , Ltd. 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.

K910173SELECTRA AND TUBING SETSK842305C.A.P.D. AUTOMATIC HEATER PDH 200K832141MICROSTAR VC1 VOLUMETRIC CYCLERK831766MICROSTAR VCIK821328C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP

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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