# K170997: CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Jul 25, 2017 after 113 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K964518 (1997). 6 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081645: Agilis NXT Steerable Introducer, Model G408324, St Jude Medical (2008) Summary page 4.

## Most influential descendants
- K231227: SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath (2023), 0 descendants of its own
- K231412: CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) (2023), 0 descendants of its own
- K212165: Reprocessed Carto Vizigo Bi-Directional Guiding Sheath (2022), 0 descendants of its own

## Recalls of this device
- Feb 16, 2024 · Class II · Z-1290-2024: Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
- Feb 21, 2023 · Class II · Z-1319-2023: Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch
- Feb 21, 2023 · Class II · Z-1320-2023: Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch
- Jun 29, 2022 · Class II · Z-1677-2022: Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices wit
- Feb 26, 2021 · Class II · Z-1287-2021: There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism
- Feb 26, 2021 · Class II · Z-1286-2021: There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism
- Feb 26, 2021 · Class II · Z-1285-2021: There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism

## Indications for use
The Biosense Webster CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The sheath curve can be visualized when used with compatible CARTO® 3 EP Navigation Systems.

Source page: https://510kreport.com/device/K170997
Methodology: https://510kreport.com/methodology