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Company-Registration
1526307804
Device Listing 1526307804
Listing Summary
#
Listing key
1526307804
Premarket submission
K254085
Device
CARTOâ„¢ 3 EP Navigation System V9.0 with PIU Plus
Applicant
Biosense Webster, Inc.
Product code
DQK
Decision date
2026-01-18
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