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FDA 510(k)

MOLECULAR ADSORBENT RECIRCULATING(MARS)

K-Number: K113313 · 2012-12-14

ApplicantGambro Renal Products, Inc.
Decision Date2012-12-14
Product CodeFLD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MOLECULAR ADSORBENT RECIRCULATING(MARS) 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 2012-12-14 under 510(k) number K113313. The device is classified under product code FLD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOLECULAR ADSORBENT RECIRCULATING(MARS)?

MOLECULAR ADSORBENT RECIRCULATING(MARS) is a medical device that received FDA 510(k) clearance on 2012-12-14. The listed applicant is Gambro Renal Products, Inc.. The 510(k) number is K113313.

When did MOLECULAR ADSORBENT RECIRCULATING(MARS) receive FDA 510(k) clearance?

MOLECULAR ADSORBENT RECIRCULATING(MARS) received FDA 510(k) clearance on 2012-12-14, under 510(k) number K113313.

Who is the listed applicant for MOLECULAR ADSORBENT RECIRCULATING(MARS)?

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 MOLECULAR ADSORBENT RECIRCULATING(MARS)?

The FDA product code for MOLECULAR ADSORBENT RECIRCULATING(MARS) is FLD.

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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.

K130039REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZERK110823PRISMAFLEXK103832PHOENIX 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

View all 11 devices →

Related Devices (Code: FLD)

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.

K033262MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)Gambro Renal ProductsK992196BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)Hemocleanse, Inc.K984546BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TKHemocleanse, Inc.K971015AHCS HEMOPERFUSION SYSTEMAmerican Health Care Systems, Inc.K953751BIOLOGIC-DT SYSTEMHemocleanse, Inc.K885017HEMOSORBA CH-500, CH-350 AND CH-180Asahi Medical Co., Ltd.

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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