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
1814346843
Device Listing 1814346843
Listing Summary
#
Listing key
1814346843
Premarket submission
K213582
Device
Epicardial Access System
Applicant
Baylis Medical Company, Inc.
Product code
DYB
Decision date
2022-06-30
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
175629
1000121056
1000121056
Boston Scientific Corporation
1
N
2026-01-01
8 Industrial Dr Coventry RI US 02816
303691
3019751610
3019751610
Aaron Dunbar
1
N
2026-01-01
300 Boston Scientific Way Marlborough MA US 01752