Atlas FDA

DIALOG WITH ADIMEA OPTION

FDA 510(k) clearance K083460 · decided 2010-02-18

Clearance details

K-number
K083460
Device name
DIALOG WITH ADIMEA OPTION
Applicant
B. Braun Avitum AG
Decision
Substantially Equivalent
Date received
2008-11-21
Decision date
2010-02-18
Days to decision
454 days
Clearance type
Traditional
Product code
KDI
Device class
2
Regulation number
876.5860
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Allentown, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and recall (Z-1531-2016)B Braun Medical Inc2016-05-03
Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # recall (Z-1532-2016)B Braun Medical Inc2016-05-03
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Ser recall (Z-1533-2016)B Braun Medical Inc2016-05-03
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U recall (Z-1534-2016)B Braun Medical Inc2016-05-03
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can b recall (Z-1535-2016)B Braun Medical Inc2016-05-03
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be recall (Z-1536-2016)B Braun Medical Inc2016-05-03

PMA approvals by this applicant

RecordFirmDate
H.E.L.P. Futura Apheresis System (P940016/S027)B. Braun Avitum AG2019-06-07
Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System (P940016/S026)B. Braun Avitum AG2019-05-22
H.E.L.P. Futura Apheresis System (P940016/S025)B. Braun Avitum AG2018-06-28
Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System (P940016/S024)B. Braun Avitum AG2017-11-07
Heparin_Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System (P940016/S023)B. Braun Avitum AG2017-07-06
H.E.L.P. Futura Apheresis System (P940016/S022)B. Braun Avitum AG2016-11-15
HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM (P940016/S021)B. Braun Avitum AG2016-09-09
H.E.L.P. PLASMAT FUTURA SYSTEM (P940016/S020)B. Braun Avitum AG2016-03-17