510(k) · Cleared
Cleared2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectranetics Corp. · PDU Catheter For Crossing Total Occlusions
Cleared on Aug 18, 2005 as substantially equivalent to K040067 (Spectranetics Corp., 2004) after a 246-day review. Its family tree reaches back 7 generations to 1989. 25 later devices descend from it.
- Decided
- Aug 18, 2005
- Review
- 246 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K890505 (1989). 26 ancestors in all, the oldest K871011 (1987). 25 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 6 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 5 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 4 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 3 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 2 generations backK031842 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2003
- 1 generation backK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
- This deviceK043465 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp. · 2005
- Descendant · cites it directly · 24 of its ownK052296 Clirpath Turbo Excimer Laser CathetersSpectranetics Corp. · 2005
- Descendant · cites it directly · 23 of its ownK052514 Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151…Spectranetics Corp. · 2005
- Descendant · 2 generations on · 22 of its ownK071227 Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX)…Spectranetics Corp. · 2007 · Recalled
- Descendant · 3 generations on · 20 of its ownK091299 Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009
- Descendant · 4 generations on · 19 of its ownK094036 Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K052296Clirpath Turbo Excimer Laser CathetersSpectranetics Corp. · 2005 · cites it directly24descendants
- K052514Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156…Spectranetics Corp. · 2005 · cites it directly23descendants
- K071227Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX)…Spectranetics Corp. · 2007 · 2 generations on22descendants
- K091299Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009 · 3 generations on20descendants
- K094036Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010 · 4 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −6 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −5 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −4 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −3 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −2 | K031842 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −1 | K040067 | Clirpath Excimer Laser Catheter | Spectranetics Corp. | 2004 | — |
| 0 (this device) | K043465 | 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011 | Spectranetics Corp. | 2005 | — |
| +1 | K052296 | Clirpath Turbo Excimer Laser Catheters | Spectranetics Corp. | 2005 | — |
| +1 | K052514 | Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152… | Spectranetics Corp. | 2005 | — |
| +2 | K071227 | Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM… | Spectranetics Corp. | 2007 | 1 |
| +3 | K091299 | Spectranetics Turbo-Tandem System | Spectranetics Corp. | 2009 | — |
| +4 | K094036 | Turbo-Tandem System Model 472-110 | Spectranetics Corp. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 5 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K040067 | Clirpath Excimer Laser CatheterSummary page 1…4875) m o o ® Device Code: MCW IDENTIFICATION OF PREDICATE DEVICES Spectranetics CLiRpath excimer laser catheters for peripheral use, cleared to market under 510(k) K040067, serve as predicate to the 2.5 mm Turbo CLiRpath Excimer Laser Catheter. -33- Ko <C1Y p. 2ot3 DEVICE DESCRIPTIO… | 2004 |
What descends from it? (25)
See all 252 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K052296 (Spectranetics Corp., 2005) has gone furthest, with 24 descendants of its own.
- 3 other devices also cite its predicate K040067.
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.
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?
For use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where totat obstructions can not be crossed with standard guide wires.
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/K043465 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043465: 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043465
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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