510(k) · Cleared
ClearedMicro Guide Catheter XP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · PDU Catheter For Crossing Total Occlusions
Cleared on Aug 25, 2008 as substantially equivalent to K021593 (Cordis Corp., 2002) after a 26-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Aug 25, 2008
- Review
- 26 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K021593 (2002). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK021593 Modification to Envoy and Vista Brite TipCordis Corp. · 2002 · Recalled
- This deviceK082143 Micro Guide Catheter XPCordis Corp. · 2008
- Descendant · cites it directly · 1 of its ownK140438 Micro Guide Catheter EliteCordis Corp., A Johnson & Johnson Co. · 2014
- Descendant · 2 generations on · 0 of its ownK150187 ELITECROSS Support CatheterCordis Corporation, A Johnson & Johnson Company · 2015
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 |
|---|---|---|---|---|---|
| −1 | K021593 | Modification to Envoy and Vista Brite Tip | Cordis Corp. | 2002 | 3 |
| 0 (this device) | K082143 | Micro Guide Catheter XP | Cordis Corp. | 2008 | — |
| +1 | K140438 | Micro Guide Catheter Elite | Cordis Corp., A Johnson & Johnson Co. | 2014 | — |
| +2 | K150187 | ELITECROSS Support Catheter | Cordis Corporation, A Johnson & Johnson Company | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K035335 | Cordis Micro Guide Catheter XP Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…Classification: Class[I, 21 CFR 870.1250 Catheter, Percutaneous Product Code: DQY The device is substantially equivalent to: * Cordis Micro Guide Catheter XP (510(k) # K035335) ¢ Cordis Vista Brite Tip® Guiding Catheter (510(k) #K021593) The Micro Guide Catheter XP is a single lumen, braided guide cathe… | |
| * | K021593 | Modification to Envoy and Vista Brite TipSummary page 1…us Product Code: DQY The device is substantially equivalent to: * Cordis Micro Guide Catheter XP (510(k) # K035335) ¢ Cordis Vista Brite Tip® Guiding Catheter (510(k) #K021593) The Micro Guide Catheter XP is a single lumen, braided guide catheter with a PTFE liner. The Micro Guide Catheter has a 4.5 Fre… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140438 | Micro Guide Catheter Elite | 2014 | 1 |
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?
- Its one ancestor has a recall.
- Of its descendants, K140438 (Cordis Corp., A Johnson & Johnson Co., 2014) has gone furthest, with 1 descendant 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. 2008, 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 XP accessory is to be used with the Frontrunner® XP CTO Catheter. The Frontrunner XP CTO Catheter is indicated to facilitate the intraluminal placement of conventional guidewires beyond the stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.
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/K082143 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082143: Micro Guide Catheter XP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082143
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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