Atlas FDA

CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)

FDA 510(k) clearance K103746 · decided 2011-01-21

Clearance details

K-number
K103746
Device name
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)
Applicant
Biosense Webster, Inc.
Decision
Substantially Equivalent
Date received
2010-12-23
Decision date
2011-01-21
Days to decision
29 days
Clearance type
Special
Product code
DQK
Device class
2
Regulation number
870.1425
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Diamond Bar, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CARTO 3 Systems, Product Code M-4800-01 The intended use of the CARTO 3 System is catheter recall (Z-1230-2012)Biosense Webster, Inc.2012-03-20

PMA approvals by this applicant

RecordFirmDate
TRUPULSE™ Generator (P240006/S012)Biosense Webster, Inc.2025-12-23
nGEN™ Pump (P990071/S068)Biosense Webster, Inc.2025-12-23
SMARTABLATE™ System Interface Cable (D-1303-02-S) (P990071/S067)Biosense Webster, Inc.2025-09-15
VARIPULSE™ Catheter (P240006/S011)Biosense Webster, Inc.2025-09-10
VARIPULSE™ Platform; VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump (P240006/S010)Biosense Webster, Inc.2025-08-07
VARIPULSE™ Platform (P240006/S009)Biosense Webster, Inc.2025-07-23
VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) (P240006/S007)Biosense Webster, Inc.2025-06-26
VARIPULSE Bi-Directional Catheter (P240006/S008)Biosense Webster, Inc.2025-06-05