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
1724992981
Device Listing 1724992981
Listing Summary
#
Listing key
1724992981
Premarket submission
K191660
Device
CARTO 3 EP Navigation System, Version 7.1 and Accessories
Applicant
Biosense Webster, Inc.
Product code
DQK
Decision date
2019-07-20
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
112859
3008203003
3008203003
Biosense Webster (Israel), Ltd.
1
N
2026-01-01
4 Hatnufa Street Yokneam Northern IL 2066717
308348
3013300026
3013300026
BIOSENSE WEBSTER, INC.
1
Y
2026-01-01
31 Technology Drive, Suite 200 -- Irvine CA US 92618