510(k) · Cleared
ClearedClirpath Turbo Peripheral Catheters
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 Sep 29, 2006 after a 269-day review. The FDA summary names no predicate by number. 23 later devices descend from it.
- Decided
- Sep 29, 2006
- Review
- 269 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 2 citing it directly.
- This deviceK060012 Clirpath Turbo Peripheral CathetersSpectranetics Corp. · 2006
- Descendant · cites it directly · 22 of its ownK071227 Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX)…Spectranetics Corp. · 2007 · Recalled
- Descendant · 2 generations on · 20 of its ownK091299 Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009
- Descendant · 3 generations on · 19 of its ownK094036 Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010
- Descendant · cites it directly · 17 of its ownK140775 Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation · 2014 · Recalled
- Descendant · 2 generations on · 8 of its ownK181642 B-Laser Atherectomy SystemEximo Medical, Ltd. · 2018
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K071227Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX)…Spectranetics Corp. · 2007 · cites it directly22descendants
- K091299Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009 · 2 generations on20descendants
- K094036Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010 · 3 generations on19descendants
- K140775Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation · 2014 · cites it directly17descendants
- K181642B-Laser Atherectomy SystemEximo Medical, Ltd. · 2018 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060012 | Clirpath Turbo Peripheral Catheters | Spectranetics Corp. | 2006 | — |
| +1 | K071227 | Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM… | Spectranetics Corp. | 2007 | 1 |
| +2 | K091299 | Spectranetics Turbo-Tandem System | Spectranetics Corp. | 2009 | — |
| +3 | K094036 | Turbo-Tandem System Model 472-110 | Spectranetics Corp. | 2010 | — |
| +1 | K140775 | Turbo-Elite Atherectomy Catheters, Turbo Tandem System | Spectranetics Corporation | 2014 | 3 |
| +2 | K181642 | B-Laser Atherectomy System | Eximo Medical, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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?
The FDA summary names no predicate by number.
What descends from it? (23)
See all 232 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?
- Of its descendants, K071227 (Spectranetics Corp., 2007) has gone furthest, with 22 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.
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 total 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/K060012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060012: Clirpath Turbo Peripheral Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060012
Report an extraction error
Are you the manufacturer?
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