510(k) · Cleared
ClearedSureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Company, Inc. · DYB Introducer, Catheter
Cleared on Dec 20, 2023 as substantially equivalent to K170997 (Biosense Webster, Inc., 2017) after a 236-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Dec 20, 2023
- Review
- 236 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K964518 (1997). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997 · Recalled
- 4 generations backK042623 Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 2005 · Recalled
- 3 generations backK061363 Agilis NXT Steerable IntroducerSt Jude Medical · 2006 · Recalled
- 2 generations backK081645 Agilis NXT Steerable Introducer, Model G408324St Jude Medical · 2008
- 1 generation backK170997 CARTO VIZIGO 8.5F Bi-Directional Guiding SheathBiosense Webster, Inc. · 2017 · Recalled
- This deviceK231227 SureFlex HD Steerable Sheath, VersaCross HD Steerable SheathBaylis Medical Company, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K964518 | Fast-Cath Transseptal Catheter Introducer | Daig Corp. | 1997 | 4 |
| −4 | K042623 | Agilis Steerable Catheter Introducer, Model 408304 | St. Jude Medical, Daig Division, Inc. | 2005 | 1 |
| −3 | K061363 | Agilis NXT Steerable Introducer | St Jude Medical | 2006 | 1 |
| −2 | K081645 | Agilis NXT Steerable Introducer, Model G408324 | St Jude Medical | 2008 | — |
| −1 | K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath | Biosense Webster, Inc. | 2017 | 7 |
| 0 (this device) | K231227 | SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath | Baylis Medical Company, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 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 |
|---|---|---|---|
| * | K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding SheathSummary page 5…evice A. Predicate Device: CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath B. Manufacturer: Biosense Webster Inc. C. 510(k) K170997 D. Indications for Use The Biosense Webster CARTO VIZIGO™ 8.5F Bi-Directional Guiding S… | 2017 |
| † | K190688 | VersaCross Steerable Sheath, VersaCross Transseptal Dilator | 2019 |
| † | K122926 | Sureflex Steerable Guiding Sheath Kit | 2013 |
| † | K183632 | Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 6.4 years on median.
- 5 of the 7 ancestors have a recall of any class.
- 2 other devices also cite its predicate K170997.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 sheath is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
The sheath curve can be visualized when used with impedance-based electroanatomical mapping systems.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231227: SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231227
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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