510(k) · Cleared
Recalled · Class II · 2025VersaCross Transseptal 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 May 20, 2019 as substantially equivalent to K102948 (Baylis Medical Co., Inc., 2011) after a 144-day review. Its family tree reaches back 2 generations to 2002. 1 of the 5 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- May 20, 2019
- Review
- 144 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013919 (2002). 2 later devices descend from it, 2 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK013919 Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2002 · Recalled
- 1 generation backK102948 Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2011 · Recalled (Class I)
- This deviceK183655 VersaCross Transseptal SheathBaylis Medical Company, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK231108 Talon Transseptal SheathInari Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK213492 Dib UltraNav Transseptal Catheter SystemDib Ultranav Medical, LLC · 2022
Class I recalls in this family
- K102948 Torflex Transseptal Guiding Sheathdirect predicate · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013919 | Torflex Transseptal Guiding Sheath | Baylis Medical Co., Inc. | 2002 | 1 |
| −1 | K102948 | Torflex Transseptal Guiding Sheath | Baylis Medical Co., Inc. | 2011 | Class I |
| 0 (this device) | K183655 | VersaCross Transseptal Sheath | Baylis Medical Company, Inc. | 2019 | — |
| +1 | K231108 | Talon Transseptal Sheath | Inari Medical, Inc. | 2023 | — |
| +1 | K213492 | Dib UltraNav Transseptal Catheter System | Dib Ultranav Medical, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K102948 | Torflex Transseptal Guiding SheathSummary page 4…ce A. Predicate Device: TorFlex Transseptal Guiding Sheath B. Manufacturer: Baylis Medical Company Inc. C. 510(k) K102948 D. Indications for Use The TorFlex™ Transseptal Guiding Sheath is used for the perc… | 2011 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 10, 2025 | Class II | Z-2103-2025 | Packaging change control | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in… |
| Jun 10, 2025 | Class II | Z-2106-2025 | Packaging change control | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in… |
| Jun 10, 2025 | Class II | Z-2105-2025 | Packaging change control | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K102948Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 2011 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 9.1 years on median.
- 2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K231108 (Inari Medical, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K102948.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 VersaCross Transseptal Sheath is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.
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/K183655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183655: VersaCross Transseptal Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183655
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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