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
1804000840
Device Listing 1804000840
Listing Summary
#
Listing key
1804000840
Premarket submission
K233207
Device
Polaris X™ Unidirectional Steerable Diagnostic Catheter
Applicant
Boston Scientific Corporation
Product code
DRF
Decision date
2023-10-27
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
122195
2124215
2124215
Boston Scientific Corporation
1
Y
2026-01-01
4100 Hamline Ave N Saint Paul MN US 55112
26758
9681260
3002806565
Boston Scientific Limited
1
N
2026-01-01
BALLYBRIT BUSINESS PARK GALWAY IE --
175629
1000121056
1000121056
Boston Scientific Corporation
1
N
2026-01-01
8 Industrial Dr Coventry RI US 02816
26737
3004859241
3004859241
Aaron Dunbar
1
N
2026-01-01
300 Boston Scientific Way Marlborough MA US 01752