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FDA 510(k)

DRAIN/PRIMING/RECIRCULATION BAG

K-Number: K913361 · 1992-03-30

ApplicantHaemotronic, Inc.
Decision Date1992-03-30
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DRAIN/PRIMING/RECIRCULATION BAG is the device name listed in this FDA 510(k) record. The listed applicant is Haemotronic, Inc.. It received FDA 510(k) clearance on 1992-03-30 under 510(k) number K913361. 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 DRAIN/PRIMING/RECIRCULATION BAG?

DRAIN/PRIMING/RECIRCULATION BAG is a medical device that received FDA 510(k) clearance on 1992-03-30. The listed applicant is Haemotronic, Inc.. The 510(k) number is K913361.

When did DRAIN/PRIMING/RECIRCULATION BAG receive FDA 510(k) clearance?

DRAIN/PRIMING/RECIRCULATION BAG received FDA 510(k) clearance on 1992-03-30, under 510(k) number K913361.

Who is the listed applicant for DRAIN/PRIMING/RECIRCULATION BAG?

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

What is the FDA product code for DRAIN/PRIMING/RECIRCULATION BAG?

The FDA product code for DRAIN/PRIMING/RECIRCULATION BAG 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 Haemotronic, 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.

K921597CAVH/CVVH/CAVHD SET MODEL #HT-HF/505K921594HAEMOTROL MODEL #HT-SB/6 BURETTE SETK921595Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2

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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