510(k) · Cleared
ClearedMicro Guide Catheter Elite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp., A Johnson & Johnson Co. · PDU Catheter For Crossing Total Occlusions
Cleared on Nov 14, 2014 as substantially equivalent to K082143 (Cordis Corp., 2008) after a 266-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Nov 14, 2014
- Review
- 266 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K021593 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK021593 Modification to Envoy and Vista Brite TipCordis Corp. · 2002 · Recalled
- 1 generation backK082143 Micro Guide Catheter XPCordis Corp. · 2008
- This deviceK140438 Micro Guide Catheter EliteCordis Corp., A Johnson & Johnson Co. · 2014
- Descendant · cites it directly · 0 of its ownK150187 ELITECROSS Support CatheterCordis Corporation, A Johnson & Johnson Company · 2015
Most influential descendants
Showing 1 of 1 · See all- K150187ELITECROSS Support CatheterCordis Corporation, A Johnson & Johnson Company · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021593 | Modification to Envoy and Vista Brite Tip | Cordis Corp. | 2002 | 3 |
| −1 | K082143 | Micro Guide Catheter XP | Cordis Corp. | 2008 | — |
| 0 (this device) | K140438 | Micro Guide Catheter Elite | Cordis Corp., A Johnson & Johnson Co. | 2014 | — |
| +1 | K150187 | ELITECROSS Support Catheter | Cordis Corporation, A Johnson & Johnson Company | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 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 |
|---|---|---|---|
| * | K082143 | Micro Guide Catheter XPSummary page 4…r for Crossing Total Occlusions (21 CFR §870.1250) Regulatory Class: Class II Product Code: PDU III. PREDICATE DEVICE Micro Guide Catheter XP, previously cleared under K082143 This predicate has not been the subject of a recall. No reference devices were used in this submission. IV. DEVICE DESCRIPTION… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150187 | ELITECROSS Support Catheter | 2015 | 0 |
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 12 years and passes through 2 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K150187 (Cordis Corporation, A Johnson & Johnson Company, 2015) has gone furthest, with 0 descendants of its own.
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. 2014, 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 Micro Guide Catheter ELITE accessory is to be used with the Frontrunner® CTO Catheter. The Frontrunner® CTO Catheter is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140438: Micro Guide Catheter Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140438
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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