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FDA 510(k)

DIALYSIS ADMIN. SET - I.V.

K-Number: K840654 · 1984-05-02

ApplicantCp Medical
Decision Date1984-05-02
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIALYSIS ADMIN. SET - I.V. is the device name listed in this FDA 510(k) record. The listed applicant is Cp Medical. It received FDA 510(k) clearance on 1984-05-02 under 510(k) number K840654. 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 DIALYSIS ADMIN. SET - I.V.?

DIALYSIS ADMIN. SET - I.V. is a medical device that received FDA 510(k) clearance on 1984-05-02. The listed applicant is Cp Medical. The 510(k) number is K840654.

When did DIALYSIS ADMIN. SET - I.V. receive FDA 510(k) clearance?

DIALYSIS ADMIN. SET - I.V. received FDA 510(k) clearance on 1984-05-02, under 510(k) number K840654.

Who is the listed applicant for DIALYSIS ADMIN. SET - I.V.?

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

What is the FDA product code for DIALYSIS ADMIN. SET - I.V.?

The FDA product code for DIALYSIS ADMIN. SET - I.V. is KOC.

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 Cp Medical 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.

K094028CP-FIBER (ORTHOFIBER)K072229MONOSWIFTK071550PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERSK060987OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31K041894ORTHOFIBERK034062CP SLEEVE AND RIVER SLEEVE

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Related Devices (Code: KOC)

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.

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.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.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, LLCK172238CAREline Airless Hemodialysis Blood Tubing SetsFresenius 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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