FDA 510(k)

NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS

K-Number: K972206 · 1997-11-26

Decision Date1997-11-26

Product CodeKOC

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corp.. It received FDA 510(k) clearance on 1997-11-26 under 510(k) number K972206. 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 BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS?

NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS is a medical device that received FDA 510(k) clearance on 1997-11-26. The listed applicant is Nipro Medical Corp.. The 510(k) number is K972206.

When did NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS receive FDA 510(k) clearance?

NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS received FDA 510(k) clearance on 1997-11-26, under 510(k) number K972206.

Who is the listed applicant for NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS?

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

What is the FDA product code for NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS?

The FDA product code for NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS is KOC.

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Other records listing Nipro Medical Corp. as applicant

K093985NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE K081210NIPRO SAFETOUCH HUBER INFUSTION SET K072024NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 K063368NIPRO BIOHOLE NEEDLE K063721NIPRO SAFETOUCH II GAMMA K052474NIPRO HYPODERMIC NEEDLE

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Related Devices (Code: KOC)

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, LLC K172238CAREline 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.