510(k) · Cleared
ClearedELITECROSS Support Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corporation, A Johnson & Johnson Company · PDU Catheter For Crossing Total Occlusions
Cleared on May 19, 2015 as substantially equivalent to K140438 (Cordis Corp., A Johnson & Johnson Co., 2014) after a 112-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- May 19, 2015
- Review
- 112 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K021593 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK021593 Modification to Envoy and Vista Brite TipCordis Corp. · 2002 · Recalled
- 2 generations backK082143 Micro Guide Catheter XPCordis Corp. · 2008
- 1 generation backK140438 Micro Guide Catheter EliteCordis Corp., A Johnson & Johnson Co. · 2014
- This deviceK150187 ELITECROSS Support CatheterCordis Corporation, A Johnson & Johnson Company · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K021593 | Modification to Envoy and Vista Brite Tip | Cordis Corp. | 2002 | 3 |
| −2 | K082143 | Micro Guide Catheter XP | Cordis Corp. | 2008 | — |
| −1 | K140438 | Micro Guide Catheter Elite | Cordis Corp., A Johnson & Johnson Co. | 2014 | — |
| 0 (this device) | K150187 | ELITECROSS Support Catheter | Cordis Corporation, A Johnson & Johnson Company | 2015 | — |
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 PDU? 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 PDU device
- #1 K262013 Kiba CTO Crossing Catheterscore 15.2 · 12 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 |
|---|---|---|---|
| * | K140438 | Micro Guide Catheter EliteSummary page 4…1250) Regulatory Class: Class 11 Product Code: PDU [II. PREDICATE DEVICE Primary Predicate: Cordis Micro Guide Catheter ELITE, previously cleared on 11/14/2014 under K140438. Regulation Number: 21 CFR §870.1250. Product Code: PDU This predicate has not been the subject of a recall. Reference Device:… | 2014 |
| † | K122796 | Cxi Support Catheter | 2012 |
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 13 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All PDU devicesPDU Catheter For Crossing Total Occlusions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PDU
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDU
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDU
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PDU
179in 2025
MAUDE reports naming product code PDU, 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 | 4 | 66 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 3 | 49 | 0 | 0 |
| 2011 | 3 | 91 | 0 | 0 |
| 2012 | 6 | 68 | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 3 | 97 | 0 | 10 |
| 2015 | 2 | — | 0 | 12 |
| 2016 | 2 | — | 0 | 26 |
| 2017 | 1 | — | 0 | 211 |
| 2018 | 0 | — | 0 | 97 |
| 2019 | 1 | — | 0 | 83 |
| 2020 | 2 | — | 2 | 129 |
| 2021 | 3 | 144 | 0 | 189 |
| 2022 | 4 | 139 | 0 | 156 |
| 2023 | 3 | 221 | 1 | 71 |
| 2024 | 1 | — | 0 | 92 |
| 2025 | 3 | 59 | 0 | 179 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Cordis ELITECROSS™ Support Catheter is intended to facilitate the intraluminal placement of diagnostic/interventional devices beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, and to deliver saline or contrast medium. Additionally, ELITECROSS™ can be used as an accessory with the FRONTRUNNER® XP CTO Catheter.
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/K150187 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150187: ELITECROSS Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150187
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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