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510(k) K113313

Device
MOLECULAR ADSORBENT RECIRCULATING(MARS)
Applicant
GAMBRO RENAL PRODUCTS, INC.
510(k) number
K113313
Product code
FLD  
Decision
Substantially Equivalent (SESE)
Decision date
2012-12-14
Date received
2011-11-09
Regulation
876.5870
Classification name
Apparatus, Hemoperfusion, Sorbent
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KAE MILLER
Address
14143 Denver W. Pkwy. Suite 400 Lakewood CO US 80401 80401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FLD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K133807MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNITGambro Renal Products, Inc.2014-03-26
K033262MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)Gambro Renal Products2005-05-27
K992196BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)Hemocleanse, Inc.1999-09-10
K984546BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TKHemocleanse, Inc.1999-08-13
K971015AHCS HEMOPERFUSION SYSTEMAmerican Health Care Systems, Inc.1997-10-22
K953751BIOLOGIC-DT SYSTEMHemocleanse, Inc.1996-02-15
K885017HEMOSORBA CH-500, CH-350 AND CH-180Asahi Medical Co., Ltd.1989-03-17
K873643GAMBRO ADSORBA 150CGambro, Inc.1987-12-29
K840532HEMOPERFUSION SYSTEM TP-400Extracorporeal Medical Specialities, Inc.1984-05-30
K831029HEMOPERFUSION SYSTEM TP-400Extracorporeal Medical Specialities, Inc.1983-08-26

Legacy Summary#

summary

FDA Review#

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