510(k) · Cleared
ClearedTruepath Cto Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · PDU Catheter For Crossing Total Occlusions
Cleared on Apr 16, 2014 as substantially equivalent to K101599 (Revascular Therapeutics, Inc., 2011) after a 70-day review. Its family tree reaches back 10 generations to 1989.
- Decided
- Apr 16, 2014
- Review
- 70 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K890505 (1989). 33 ancestors in all, the oldest K871011 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 6 generations between
- 3 generations backK072776 The Crosser SystemFlowcardia, Inc. · 2007 · Recalled
- 2 generations backK091119 Modification to the Crosser SystemFlowcardia, Inc. · 2009
- 1 generation backK101599 RVT Cto DeviceRevascular Therapeutics, Inc. · 2011
- This deviceK140288 Truepath Cto DeviceBoston Scientific Corp · 2014
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 backK032031 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004
- 4 generations backK062868 The Crosser Catheter, Model CR1100 and System Electronics, Model…Flowcardia, Inc. · 2007
- 3 generations backK072776 The Crosser SystemFlowcardia, Inc. · 2007 · Recalled
- 2 generations backK091119 Modification to the Crosser SystemFlowcardia, Inc. · 2009
- 1 generation backK101599 RVT Cto DeviceRevascular Therapeutics, Inc. · 2011
- This deviceK140288 Truepath Cto DeviceBoston Scientific Corp · 2014
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 | K032031 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2004 | — |
| −4 | K062868 | The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02 | Flowcardia, Inc. | 2007 | — |
| −3 | K072776 | The Crosser System | Flowcardia, Inc. | 2007 | 1 |
| −2 | K091119 | Modification to the Crosser System | Flowcardia, Inc. | 2009 | — |
| −1 | K101599 | RVT Cto Device | Revascular Therapeutics, Inc. | 2011 | — |
| 0 (this device) | K140288 | Truepath Cto Device | Boston Scientific Corp | 2014 | — |
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 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K101599 | RVT Cto DeviceSummary page 2…appropriate for its intended use and is considered to be substantially equivalent to the RVT (TruePath) CTO Device as submitted in K101599. Boston Scientific Corporation Page 2 of 2… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 33 ancestors have a recall of any class.
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 TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions.
Contraindications:
The device is contraindicated for use in carotid arteries.
The TruePath Extension Wire is designed to extend the TruePath OTO Device so that a catheter can be exchanged for another catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140288: Truepath Cto Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140288
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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