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FDA 510(k)

SARTORIUS MINISART SM 16596HY

K-Number: K844504 · 1985-01-18

ApplicantSartorius Filters, Inc.
Decision Date1985-01-18
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SARTORIUS MINISART SM 16596HY is the device name listed in this FDA 510(k) record. The listed applicant is Sartorius Filters, Inc.. It received FDA 510(k) clearance on 1985-01-18 under 510(k) number K844504. 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 SARTORIUS MINISART SM 16596HY?

SARTORIUS MINISART SM 16596HY is a medical device that received FDA 510(k) clearance on 1985-01-18. The listed applicant is Sartorius Filters, Inc.. The 510(k) number is K844504.

When did SARTORIUS MINISART SM 16596HY receive FDA 510(k) clearance?

SARTORIUS MINISART SM 16596HY received FDA 510(k) clearance on 1985-01-18, under 510(k) number K844504.

Who is the listed applicant for SARTORIUS MINISART SM 16596HY?

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

What is the FDA product code for SARTORIUS MINISART SM 16596HY?

The FDA product code for SARTORIUS MINISART SM 16596HY is KOC.

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Other records listing Sartorius Filters, 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.

K851818SARTORIUS MINI SART FH 16592K851816SARTORIUS MINISART FH 16534K851817SARTORIUS MINI-SART FH 16555K850435SARTORIUS AQUASART SM 40035 - DIALYSATE SYSK830487HEMO-PROCESSING SYSTEMK823132SARTOPHOR SYSTEM FOR ELECTROPHORESIS

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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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