FDA 510(k)

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath

K-Number: K170997 · 2017-07-25

Decision Date2017-07-25

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Biosense Webster, Inc.. It received FDA 510(k) clearance on 2017-07-25 under 510(k) number K170997. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath?

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath is a medical device that received FDA 510(k) clearance on 2017-07-25. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K170997.

When did CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath receive FDA 510(k) clearance?

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath received FDA 510(k) clearance on 2017-07-25, under 510(k) number K170997.

Who is the listed applicant for CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath?

The FDA 510(k) record lists Biosense Webster, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath?

The FDA product code for CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath is DYB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02565069Identification for the Treatment of Complex ArrhythmiasCOMPLETED NCT04750798An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac ArrhythmiasRECRUITING NCT05565599An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial FibrillationACTIVE_NOT_RECRUITING NCT06168942A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage EliminationSUSPENDED NCT07116525A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping CatheterRECRUITING NCT07227532A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter SystemRECRUITING

Other records listing Biosense Webster, Inc. as applicant

PMA P030031catheter, percutaneous, cardiac ablation, for treatment of atrial flutter PMA P240006Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation PMA P210027Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation K252972CARTO™ 3 EP Navigation System V8.4 K254085CARTO™ 3 EP Navigation System V9.0 with PIU Plus PMA P990071Cardiac ablation percutaneous catheter

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Related Devices (Code: DYB)

K253526NAMIC Dilator and SheathMedline Industries, LP K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLC K261242SimplGuidePendracare K261950Health Line Tearaway IntroducerHealth Line International Corporation K261492FieldFlex Steerable SheathCenterPoint Systems, LLC K260606Echo Large Bore Introducer SheathEcho Medical, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.