Atlas FDA

SOLCART B

FDA 510(k) clearance K102194 · decided 2011-04-25

Clearance details

K-number
K102194
Device name
SOLCART B
Applicant
B. Braun Avitum AG
Decision
Substantially Equivalent
Date received
2010-08-04
Decision date
2011-04-25
Days to decision
264 days
Clearance type
Traditional
Product code
KPO
Device class
2
Regulation number
876.5820
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

No recalls on record reference this clearance.

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