Atlas FDA

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath

FDA 510(k) clearance K170997 · decided 2017-07-25

Clearance details

K-number
K170997
Device name
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
Applicant
Biosense Webster, Inc.
Decision
Substantially Equivalent
Date received
2017-04-03
Decision date
2017-07-25
Days to decision
113 days
Clearance type
Traditional
Product code
DYB
Device class
2
Regulation number
870.1340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Irvin, CA, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
NAMIC Dilator and Sheath (K253526)Medline Industries, LP2026-07-29
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Recalls involving this device

RecordFirmDate
CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional recall (Z-1290-2024)Biosense Webster, Inc.2024-03-13
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, recall (Z-1319-2023)Biosense Webster, Inc.2023-04-01
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S recall (Z-1320-2023)Biosense Webster, Inc.2023-04-01

PMA approvals by this applicant

RecordFirmDate
Dual Energy THERMOCOOL SMARTTOUCH SF™ System (P030031/S141)Biosense Webster, Inc.2026-07-01
VARIPULSE™ Catheter, TRUPULSE™ Generator with Connection Interface Unit (CIU) (P240006/S016)Biosense Webster, Inc.2026-06-30
VISITAG SURPOINT™ External Processing Unit (“EPU”); CARTO 3 System (P030031/S143)Biosense Webster, Inc.2026-06-30
THERMOCOOL SMARTTOUCH SF (Uni-Directional and Bi-Directional)/DUAL ENERGYTHERMOCOOL SMARTTOUCH SF CATHETERS (P030031/S144)Biosense Webster, Inc.2026-06-10
QDOT MICRO™ System (P210027/S016)Biosense Webster, Inc.2026-04-17
VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) (P240006/S014)Biosense Webster, Inc.2026-02-12
VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump (P240006/S013)Biosense Webster, Inc.2026-01-02
TRUPULSE™ Generator (P240006/S012)Biosense Webster, Inc.2025-12-23