510(k) · Cleared
ClearedTigereye ST CTO-Crossing Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avinger, Inc. · PDU Catheter For Crossing Total Occlusions
Cleared on Apr 25, 2023 as substantially equivalent to K201330 (Avinger, Inc., 2020) after a 53-day review. Its family tree reaches back 12 generations to 1989. 1 of the 52 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 25, 2023
- Review
- 53 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K890505 (1989). 51 ancestors in all, the oldest K861606 (1986). No later device cites it as a predicate yet. 1 of the 52 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 8 generations between
- 3 generations backK122380 Ocelot SystemAvinger, Inc. · 2012
- 2 generations backK123532 Ocelot Pixl CatheterAvinger, Inc. · 2012
- 1 generation backK201330 Tigereye CTO-Crossing CatheterAvinger, Inc. · 2020
- This deviceK230594 Tigereye ST CTO-Crossing CatheterAvinger, Inc. · 2023
Show all 12 generations
- Root · 12 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 11 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 10 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 9 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 8 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 7 generations backK032031 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004
- 6 generations backK062868 The Crosser Catheter, Model CR1100 and System Electronics, Model…Flowcardia, Inc. · 2007
- 5 generations backK072776 The Crosser SystemFlowcardia, Inc. · 2007 · Recalled
- 4 generations backK111338 Wildcat CatheterAvinger, Inc. · 2011
- 3 generations backK122380 Ocelot SystemAvinger, Inc. · 2012
- 2 generations backK123532 Ocelot Pixl CatheterAvinger, Inc. · 2012
- 1 generation backK201330 Tigereye CTO-Crossing CatheterAvinger, Inc. · 2020
- This deviceK230594 Tigereye ST CTO-Crossing CatheterAvinger, Inc. · 2023
Class I recalls in this family
- K060327 Vascular Solutions Twin-Pass Dual Access…8 generations back · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −11 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −10 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −9 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −8 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −7 | K032031 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2004 | — |
| −6 | K062868 | The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02 | Flowcardia, Inc. | 2007 | — |
| −5 | K072776 | The Crosser System | Flowcardia, Inc. | 2007 | 1 |
| −4 | K111338 | Wildcat Catheter | Avinger, Inc. | 2011 | — |
| −3 | K122380 | Ocelot System | Avinger, Inc. | 2012 | — |
| −2 | K123532 | Ocelot Pixl Catheter | Avinger, Inc. | 2012 | — |
| −1 | K201330 | Tigereye CTO-Crossing Catheter | Avinger, Inc. | 2020 | — |
| 0 (this device) | K230594 | Tigereye ST CTO-Crossing Catheter | Avinger, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 1 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K201330 | Tigereye CTO-Crossing CatheterSummary page 4…ry Class II Predicate Device Trade Name Tigereye CTO-Crossing Catheter Common Name Tigereye Premarket Notification K201330 Regulation Number and 21 CFR§870.1250, Catheter for Crossing Total Classification Name Occlusions… | 2020 |
| † | K212468 | Tigereye CTO-Crossing Catheter | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · 8 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 51 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K201330.
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. 2023, 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 Tigereye ST System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230594 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230594: Tigereye ST CTO-Crossing Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230594
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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