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FDA 510(k)

REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER

K-Number: K130039 · 2013-05-02

ApplicantGambro Renal Products, Inc.
Decision Date2013-05-02
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER 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 2013-05-02 under 510(k) number K130039. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER?

REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER is a medical device that received FDA 510(k) clearance on 2013-05-02. The listed applicant is Gambro Renal Products, Inc.. The 510(k) number is K130039.

When did REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER receive FDA 510(k) clearance?

REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER received FDA 510(k) clearance on 2013-05-02, under 510(k) number K130039.

Who is the listed applicant for REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER?

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 REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER?

The FDA product code for REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER is KDI.

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Other records listing Gambro Renal Products, 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.

K113313MOLECULAR 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-132K100364GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520K093608GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H

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Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius 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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