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FDA 510(k)

NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS

K-Number: K954676 · 1997-03-04

ApplicantNissho Corp.
Decision Date1997-03-04
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Nissho Corp.. It received FDA 510(k) clearance on 1997-03-04 under 510(k) number K954676. 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 NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS?

NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS is a medical device that received FDA 510(k) clearance on 1997-03-04. The listed applicant is Nissho Corp.. The 510(k) number is K954676.

When did NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS receive FDA 510(k) clearance?

NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS received FDA 510(k) clearance on 1997-03-04, under 510(k) number K954676.

Who is the listed applicant for NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS?

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

What is the FDA product code for NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS?

The FDA product code for NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS is KOC.

Related Clinical Trials

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Other records listing Nissho Corp. 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.

K955182NIPRO ARTERIAL VENOUS FISTULA NEEDLEK960051NIPRO SAFELET CATHK955053NIPRO SCALP VEIN SET (DISPOSABL PSV SET)K944355NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLES

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

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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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