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
1870966068
Device Listing 1870966068
Listing Summary
#
Listing key
1870966068
Premarket submission
K090914
Device
AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E
Applicant
Xoft, Inc.
Product code
JAD
Decision date
2009-07-16
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
228750
3015232217
3015232217
ELEKTA SOLUTIONS AB
1
N
2026-01-01
Hagaplan 4 STOCKHOLM SE 11368
334870
3032638959
3032638959
Elekta Inc.
1
N
2026-01-01
101 Nicholson Ln San Jose CA US 95134