510(k) · Cleared
ClearedReprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Health, LLC · PNE Reprocessed Catheter Introducer
Cleared on Apr 4, 2024 as substantially equivalent to K190688 (Baylis Medical Company, Inc., 2019) and 1 other predicate after a 269-day review. Its family tree reaches back 2 generations to 2013.
- Decided
- Apr 4, 2024
- Review
- 269 days
- Class
- Class II
- Product code
- PNE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K122926 (2013). No later device cites it as a predicate yet.
- Root · 2 generations backK122926 Sureflex Steerable Guiding Sheath KitBaylis Medical Co., Inc. · 2013
- 1 generation backK190688 VersaCross Steerable Sheath, VersaCross Transseptal DilatorBaylis Medical Company, Inc. · 2019
- This deviceK232037 Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex…Innovative Health, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K122926 | Sureflex Steerable Guiding Sheath Kit | Baylis Medical Co., Inc. | 2013 | — |
| −1 | K190688 | VersaCross Steerable Sheath, VersaCross Transseptal Dilator | Baylis Medical Company, Inc. | 2019 | — |
| 0 (this device) | K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable… | Innovative Health, LLC | 2024 | — |
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 PNE? 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 PNE device
- #1 K250305 Reprocessed Agilis NxT Steerable Introducerscore 14.8 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K190688 | VersaCross Steerable Sheath, VersaCross Transseptal DilatorSummary page 6…340 Product Code: PNE Predicate Device: 510(k) Number 510(k) Device Manufacturer K190688 VersaCross Steerable Sheath Baylis Medical VersaCross Transseptal Di… | 2019 |
| * | K122926 | Sureflex Steerable Guiding Sheath KitSummary page 6…nsseptal Dilator Company, Inc. Additional Predicate Device: 510(k) Number 510(k) Device Manufacturer K122926 SureFlex Steerable Guiding Sheath Kit Baylis Medical… | 2013 |
| † | K170311 | Reprocessed Agilis NxT Steerable Introducer | 2017 |
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 11 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All PNE devicesPNE Reprocessed Catheter Introducer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · PNE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNE
Too few PNE 510(k)s in any year since 2007 to give a median.
Recalls per year · PNE
No recall names PNE since 2007.
Adverse event reports per year · PNE
4in 2024
MAUDE reports naming product code PNE, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Reprocessed VersaCross Steerable Sheath is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
The Reprocessed SureFlex Steerable Guiding Sheath is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
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/K232037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232037: Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable 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/K232037
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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