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FDA 510(k)

ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE

K-Number: K822225 · 1982-08-16

ApplicantErika, Inc.
Decision Date1982-08-16
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE is the device name listed in this FDA 510(k) record. The listed applicant is Erika, Inc.. It received FDA 510(k) clearance on 1982-08-16 under 510(k) number K822225. 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 ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE?

ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE is a medical device that received FDA 510(k) clearance on 1982-08-16. The listed applicant is Erika, Inc.. The 510(k) number is K822225.

When did ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE receive FDA 510(k) clearance?

ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE received FDA 510(k) clearance on 1982-08-16, under 510(k) number K822225.

Who is the listed applicant for ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE?

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

What is the FDA product code for ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE?

The FDA product code for ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE is KOC.

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Other records listing Erika, 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.

K853134NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8K852310NATURALYTE BICARBONATE CONCENTRATE-DRY PACKK852309ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1K850866TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1LK850865TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-K850654TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID

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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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