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FDA 510(k)

SINGLE NEEDLE HEMODIALYSIS (BFC-161)

K-Number: K761081 · 1976-12-06

ApplicantSorensen Research
Decision Date1976-12-06
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SINGLE NEEDLE HEMODIALYSIS (BFC-161) is the device name listed in this FDA 510(k) record. The listed applicant is Sorensen Research. It received FDA 510(k) clearance on 1976-12-06 under 510(k) number K761081. 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 SINGLE NEEDLE HEMODIALYSIS (BFC-161)?

SINGLE NEEDLE HEMODIALYSIS (BFC-161) is a medical device that received FDA 510(k) clearance on 1976-12-06. The listed applicant is Sorensen Research. The 510(k) number is K761081.

When did SINGLE NEEDLE HEMODIALYSIS (BFC-161) receive FDA 510(k) clearance?

SINGLE NEEDLE HEMODIALYSIS (BFC-161) received FDA 510(k) clearance on 1976-12-06, under 510(k) number K761081.

Who is the listed applicant for SINGLE NEEDLE HEMODIALYSIS (BFC-161)?

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

What is the FDA product code for SINGLE NEEDLE HEMODIALYSIS (BFC-161)?

The FDA product code for SINGLE NEEDLE HEMODIALYSIS (BFC-161) is KOC.

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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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