510(k) · Cleared
Recalled · Class II · 2024CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosense Webster, Inc. · DYB Introducer, Catheter
Cleared on Jul 25, 2017 as substantially equivalent to K081645 (St Jude Medical, 2008) after a 113-day review. Its family tree reaches back 4 generations to 1997. 3 later devices descend from it. It has been recalled 7 times.
- Decided
- Jul 25, 2017
- Review
- 113 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 4 generations to K964518 (1997). 6 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997 · Recalled
- 3 generations backK042623 Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 2005 · Recalled
- 2 generations backK061363 Agilis NXT Steerable IntroducerSt Jude Medical · 2006 · Recalled
- 1 generation backK081645 Agilis NXT Steerable Introducer, Model G408324St Jude Medical · 2008
- This deviceK170997 CARTO VIZIGO 8.5F Bi-Directional Guiding SheathBiosense Webster, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK231227 SureFlex HD Steerable Sheath, VersaCross HD Steerable SheathBaylis Medical Company, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK231412 CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S…Biosense Webster, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK212165 Reprocessed Carto Vizigo Bi-Directional Guiding SheathInnovative Health, LLC · 2022
Most influential descendants
Showing 3 of 3 · See all- K231227SureFlex HD Steerable Sheath, VersaCross HD Steerable SheathBaylis Medical Company, Inc. · 2023 · cites it directly0descendants
- K231412CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)Biosense Webster, Inc. · 2023 · cites it directly0descendants
- K212165Reprocessed Carto Vizigo Bi-Directional Guiding SheathInnovative Health, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964518 | Fast-Cath Transseptal Catheter Introducer | Daig Corp. | 1997 | 4 |
| −3 | K042623 | Agilis Steerable Catheter Introducer, Model 408304 | St. Jude Medical, Daig Division, Inc. | 2005 | 1 |
| −2 | K061363 | Agilis NXT Steerable Introducer | St Jude Medical | 2006 | 1 |
| −1 | K081645 | Agilis NXT Steerable Introducer, Model G408324 | St Jude Medical | 2008 | — |
| 0 (this device) | K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath | Biosense Webster, Inc. | 2017 | — |
| +1 | K231227 | SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath | Baylis Medical Company, Inc. | 2023 | — |
| +1 | K231412 | CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S… | Biosense Webster, Inc. | 2023 | — |
| +1 | K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding Sheath | Innovative Health, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DYB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081645 | Agilis NXT Steerable Introducer, Model G408324Summary page 4…D-1385-01-S, D-1385-02-S, D-1385-03-S PREDICATE DEVICE St. Jude Agilis™ NxT Steerable Introducer [510(k) K081645] REFERENCE DEVICE Webster® CS Catheter with EZ Steer® Technology [510… | 2008 |
| † | K101345 | Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ Steer… | 2010 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 16, 2024 | Class II | Z-1290-2024 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Material/Component Contamination | 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 with a compromised sterile barrier could… |
| Feb 26, 2021 | Class II | Z-1287-2021 | Device Design | 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 | Device Design | 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 | Device Design | 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 |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K231227 (Baylis Medical Company, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 15 other devices also cite its predicate K081645.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170997: CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170997
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026