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FDA 510(k)

GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520

K-Number: K100364 · 2010-11-03

ApplicantGambro Renal Products, Inc.
Decision Date2010-11-03
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 is the device name listed in this FDA 510(k) record. The listed applicant is Gambro Renal Products, Inc.. It received FDA 510(k) clearance on 2010-11-03 under 510(k) number K100364. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520?

GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 is a medical device that received FDA 510(k) clearance on 2010-11-03. The listed applicant is Gambro Renal Products, Inc.. The 510(k) number is K100364.

When did GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 receive FDA 510(k) clearance?

GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 received FDA 510(k) clearance on 2010-11-03, under 510(k) number K100364.

Who is the listed applicant for GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520?

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

What is the FDA product code for GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520?

The FDA product code for GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 is FJK.

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Other records listing Gambro Renal Products, Inc. as applicant

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K130039REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZERK113313MOLECULAR ADSORBENT RECIRCULATING(MARS)K110823PRISMAFLEXK103832PHOENIX HEMODIALYSIS DELIVERY SYSTEMK100451GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132K093608GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H

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Related Devices (Code: FJK)

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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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