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Company-Registration
1259048607
Device Listing 1259048607
Listing Summary
#
Listing key
1259048607
Premarket submission
K231207
Device
CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
Applicant
Biosense Webster, Inc.
Product code
DQK
Decision date
2023-09-07
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
314019
3022451073
3022451073
BIOSENSE WEBSTER, INC.
1
N
2026-01-01
23 Hubble Drive Irvine CA US 92618