510(k) · Cleared
Recalled · 2008Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, Model 310-154, 314-159, 317-15
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 Jul 11, 2007 as substantially equivalent to K060012 (Spectranetics Corp., 2006) and 2 other predicates after a 69-day review. Its family tree reaches back 10 generations to 1989. 22 later devices descend from it. It has been recalled once.
- Decided
- Jul 11, 2007
- Review
- 69 days
- Class
- Class II
- Product code
- PDU
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 10 generations to K890505 (1989). 30 ancestors in all, the oldest K871011 (1987). 22 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 6 generations between
- 3 generations backK043465 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp. · 2005
- 2 generations backK052296 Clirpath Turbo Excimer Laser CathetersSpectranetics Corp. · 2005
- 1 generation backK052514 Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151…Spectranetics Corp. · 2005
- This deviceK071227 Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX)…Spectranetics Corp. · 2007
- Descendant · cites it directly · 20 of its ownK091299 Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009
- Descendant · 2 generations on · 19 of its ownK094036 Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010
- Descendant · 2 generations on · 17 of its ownK140775 Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation · 2014 · Recalled
- Descendant · 3 generations on · 8 of its ownK181642 B-Laser Atherectomy SystemEximo Medical, Ltd. · 2018
- Descendant · 4 generations on · 6 of its ownK202835 Auryon Atherectomy SystemEximo Medical, Ltd. · 2020
Show all 10 generations
- Root · 10 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 9 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 8 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 7 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 6 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 5 generations backK031842 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2003
- 4 generations backK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
- 3 generations backK043465 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp. · 2005
- 2 generations backK052296 Clirpath Turbo Excimer Laser CathetersSpectranetics Corp. · 2005
- 1 generation backK052514 Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151…Spectranetics Corp. · 2005
- This deviceK071227 Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX)…Spectranetics Corp. · 2007
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K091299Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009 · cites it directly20descendants
- K094036Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010 · 2 generations on19descendants
- K140775Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation · 2014 · 2 generations on17descendants
- K181642B-Laser Atherectomy SystemEximo Medical, Ltd. · 2018 · 3 generations on8descendants
- K202835Auryon Atherectomy SystemEximo Medical, Ltd. · 2020 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −9 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −8 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −7 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −6 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −5 | K031842 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −4 | K040067 | Clirpath Excimer Laser Catheter | Spectranetics Corp. | 2004 | — |
| −3 | K043465 | 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011 | Spectranetics Corp. | 2005 | — |
| −2 | 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 | — |
| 0 (this device) | K071227 | Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM… | Spectranetics Corp. | 2007 | — |
| +1 | K091299 | Spectranetics Turbo-Tandem System | Spectranetics Corp. | 2009 | — |
| +2 | K094036 | Turbo-Tandem System Model 472-110 | Spectranetics Corp. | 2010 | — |
| +2 | K140775 | Turbo-Elite Atherectomy Catheters, Turbo Tandem System | Spectranetics Corporation | 2014 | 3 |
| +3 | K181642 | B-Laser Atherectomy System | Eximo Medical, Ltd. | 2018 | — |
| +4 | K202835 | Auryon Atherectomy System | Eximo Medical, Ltd. | 2020 | — |
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 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K060012 | Clirpath Turbo Peripheral CathetersSummary page 1…ION OF PREDICATE DEVICES Spectranetics TURBO elite™ excimer laser catheters are substantially equivalent to the same product line, TURBO elite™ excimer laser catheters (K060012). Spectranetics CLiRpath® Turbo excimer laser catheters are substantially equivalent to the same product line, CLiRpath® Turbo ex… | 2006 |
| * | K052296 | Clirpath Turbo Excimer Laser CathetersSummary page 1…catheters (K060012). Spectranetics CLiRpath® Turbo excimer laser catheters are substantially equivalent to the same product line, CLiRpath® Turbo excimer laser catheter (K052296 and K052514) Section9 pg.2 DEVICE DESCRIPTION(S) The CLiRpath® Turbo excimer laser catheters and the TURBO elit… | 2005 |
| * | K052514 | Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156…Summary page 1…060012). Spectranetics CLiRpath® Turbo excimer laser catheters are substantially equivalent to the same product line, CLiRpath® Turbo excimer laser catheter (K052296 and K052514) Section9 pg.2 DEVICE DESCRIPTION(S) The CLiRpath® Turbo excimer laser catheters and the TURBO elite™ excimer l… | 2005 |
What descends from it? (22)
See all 222 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 4, 2008 | Not classified | Z-0976-2009 | Error in labeling | The catheter pouch label was incorrectly labeled with the wrong size. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 30 ancestors has a recall of any class.
- Of its descendants, K091299 (Spectranetics Corp., 2009) has gone furthest, with 20 descendants of its own.
- 1 other device also cites its predicate K060012.
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. 2007, 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?
For use in the treatment of infrainguinal stenoses and occlusions.
For use in the treatment of infrainguinal stenoses and occlusions.
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/K071227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071227: Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, Model 310-154, 314-159, 317-15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071227
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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