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FDA 510(k)

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath

K-Number: K170997 · 2017-07-25

ApplicantBiosense Webster, Inc.
Decision Date2017-07-25
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

When was CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath approved by the FDA?

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

What company makes CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath?

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath is manufactured by Biosense Webster, Inc..

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.

Other Devices by Biosense Webster, Inc.

K170600CARTO 3 EP Navigation System, Version 6.0 and Accessories K173978CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module K173977CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT K191660CARTO 3 EP Navigation System, Version 7.1 and Accessories K200484CARTO® 3 EP Navigation System with Signal Processing Unit

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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.

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