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Company-Registration
1471279712
Device Listing 1471279712
Listing Summary
#
Listing key
1471279712
Premarket submission
K221414
Device
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
Applicant
Silk Road Medical, Inc.
Product code
LIT
Decision date
2022-09-02
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
332133
3022627847
3022627847
Silk Road Medical
1
Y
2026-01-01
14755 27th Avenue North Plymouth MN US 55447