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FDA 510(k)

GAMBRO PLASMAFILTRATION SYSTEM

K-Number: K850621 · 1985-05-16

ApplicantGambro, Inc.
Decision Date1985-05-16
Product CodeLKN
DecisionSubstantially Equivalent

Device Summary

GAMBRO PLASMAFILTRATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1985-05-16 under 510(k) number K850621. The device is classified under product code LKN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO PLASMAFILTRATION SYSTEM?

GAMBRO PLASMAFILTRATION SYSTEM is a medical device that received FDA 510(k) clearance on 1985-05-16. The listed applicant is Gambro, Inc.. The 510(k) number is K850621.

When did GAMBRO PLASMAFILTRATION SYSTEM receive FDA 510(k) clearance?

GAMBRO PLASMAFILTRATION SYSTEM received FDA 510(k) clearance on 1985-05-16, under 510(k) number K850621.

Who is the listed applicant for GAMBRO PLASMAFILTRATION SYSTEM?

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

What is the FDA product code for GAMBRO PLASMAFILTRATION SYSTEM?

The FDA product code for GAMBRO PLASMAFILTRATION SYSTEM is LKN.

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Other records listing Gambro, 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.

K083158EXALIS, SOFTWARE VERSION 1.15K070643PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35K032431PRISMA M60/M100 SETSK896758GAMBRO BICARBONATE MONITOR BCM 10-3K896757GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWSK902481GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER

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Related Devices (Code: LKN)

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.

K192150AMICUS Separator SystemFresenius Kabi AGK183081Spectra Optia Apheresis SystemTerumobct, Inc.K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterFresenius Kabi USA,LlcK181049Spectra Optia Apheresis SystemTerumobct, Inc.K172590Spectra Optia Apheresis SystemTerumobct, Inc.K153601Spectra Optia Apheresis SystemTerumobct, Inc.

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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