Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1032695987
Device Listing 1032695987
Listing Summary
#
Listing key
1032695987
Premarket submission
K051520
Device
GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H
Applicant
Gambro Renal Products
Product code
KDI
Decision date
2005-12-09
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
18600
9611369
3002807035
GAMBRO DIALYSATOREN GMBH
1
N
2026-01-01
HOLGER - CRAFOORD - STRASSE 26 HECHINGEN Baden-Wurttemberg DE 72379
340734
3038195011
3038195011
Vantive US Healthcare LLC
1
Y
2026-01-01
510 Lake Cook Rd Deerfield IL US 60015