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FDA 510(k)

BI-FLOW NEEDLE

K-Number: K761051 · 1976-12-30

ApplicantDws, Inc.
Decision Date1976-12-30
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BI-FLOW NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Dws, Inc.. It received FDA 510(k) clearance on 1976-12-30 under 510(k) number K761051. 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 BI-FLOW NEEDLE?

BI-FLOW NEEDLE is a medical device that received FDA 510(k) clearance on 1976-12-30. The listed applicant is Dws, Inc.. The 510(k) number is K761051.

When did BI-FLOW NEEDLE receive FDA 510(k) clearance?

BI-FLOW NEEDLE received FDA 510(k) clearance on 1976-12-30, under 510(k) number K761051.

Who is the listed applicant for BI-FLOW NEEDLE?

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

What is the FDA product code for BI-FLOW NEEDLE?

The FDA product code for BI-FLOW NEEDLE 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 Dws, Inc. 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.

K761050HEPARIN PUMP

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.

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.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.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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