510(k) · Cleared
ClearedAuryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eximo Medical, Ltd. · MCW Catheter, Peripheral, Atherectomy
Cleared on Dec 15, 2023 as substantially equivalent to K230709 (Eximo Medical, Ltd., 2023) after a 30-day review. Its family tree reaches back 18 generations to 1989. 2 later devices descend from it.
- Decided
- Dec 15, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K890505 (1989). 44 ancestors in all, the oldest K871011 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 18 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 14 generations between
- 3 generations backK202835 Auryon Atherectomy SystemEximo Medical, Ltd. · 2020
- 2 generations backK220116 Auryon Atherectomy CathetersEximo Medical, Ltd. · 2022
- 1 generation backK230709 Auryon Atherectomy SystemEximo Medical, Ltd. · 2023
- This deviceK233668 Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating…Eximo Medical, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK260244 Auryon Atherectomy SystemEximo Medical · 2026
- Descendant · cites it directly · 0 of its ownK241553 Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter…Eximo Medical, Ltd. · 2024 · Recalled
Show all 18 generations
- Root · 18 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 17 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 16 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 15 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 14 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 13 generations backK031842 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2003
- 12 generations backK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
- 11 generations backK043465 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp. · 2005
- 10 generations backK052296 Clirpath Turbo Excimer Laser CathetersSpectranetics Corp. · 2005
- 9 generations backK052514 Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151…Spectranetics Corp. · 2005
- 8 generations backK071227 Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX)…Spectranetics Corp. · 2007 · Recalled
- 7 generations backK091299 Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009
- 6 generations backK094036 Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010
- 5 generations backK140775 Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation · 2014 · Recalled
- 4 generations backK181642 B-Laser Atherectomy SystemEximo Medical, Ltd. · 2018
- 3 generations backK202835 Auryon Atherectomy SystemEximo Medical, Ltd. · 2020
- 2 generations backK220116 Auryon Atherectomy CathetersEximo Medical, Ltd. · 2022
- 1 generation backK230709 Auryon Atherectomy SystemEximo Medical, Ltd. · 2023
- This deviceK233668 Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating…Eximo Medical, Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −17 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −16 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −15 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −14 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −13 | K031842 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −12 | K040067 | Clirpath Excimer Laser Catheter | Spectranetics Corp. | 2004 | — |
| −11 | K043465 | 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011 | Spectranetics Corp. | 2005 | — |
| −10 | K052296 | Clirpath Turbo Excimer Laser Catheters | Spectranetics Corp. | 2005 | — |
| −9 | K052514 | Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152… | Spectranetics Corp. | 2005 | — |
| −8 | K071227 | Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM… | Spectranetics Corp. | 2007 | 1 |
| −7 | K091299 | Spectranetics Turbo-Tandem System | Spectranetics Corp. | 2009 | — |
| −6 | K094036 | Turbo-Tandem System Model 472-110 | Spectranetics Corp. | 2010 | — |
| −5 | K140775 | Turbo-Elite Atherectomy Catheters, Turbo Tandem System | Spectranetics Corporation | 2014 | 3 |
| −4 | K181642 | B-Laser Atherectomy System | Eximo Medical, Ltd. | 2018 | — |
| −3 | K202835 | Auryon Atherectomy System | Eximo Medical, Ltd. | 2020 | — |
| −2 | K220116 | Auryon Atherectomy Catheters | Eximo Medical, Ltd. | 2022 | — |
| −1 | K230709 | Auryon Atherectomy System | Eximo Medical, Ltd. | 2023 | — |
| 0 (this device) | K233668 | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000)… | Eximo Medical, Ltd. | 2023 | — |
| +1 | K260244 | Auryon Atherectomy System | Eximo Medical | 2026 | — |
| +1 | K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm… | Eximo Medical, Ltd. | 2024 | 1 |
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 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 MCW? 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 MCW device
- #1 K260244 Auryon Atherectomy Systemscore 16.5 · 19 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 |
|---|---|---|---|
| * | K230709 | Auryon Atherectomy SystemSummary page 4…Cardiovascular Devices Predicate Device 510(k) Reference K230709 Trade Name: Auryon™ Atherectomy System Common Name:… | 2023 |
What descends from it? (2)
2 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 34 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 44 ancestors have a recall of any class.
- Of its descendants, K260244 (Eximo Medical, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MCW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MCW
46in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MCW
2in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MCW
677in 2025
MAUDE reports naming product code MCW, 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 | 5 | 43 | 2 | 50 |
| 2008 | 6 | 33 | 1 | 115 |
| 2009 | 8 | 27 | 3 | 105 |
| 2010 | 6 | 30 | 1 | 167 |
| 2011 | 6 | 39 | 0 | 204 |
| 2012 | 5 | 29 | 0 | 194 |
| 2013 | 5 | 30 | 0 | 134 |
| 2014 | 7 | 117 | 0 | 210 |
| 2015 | 6 | 30 | 0 | 377 |
| 2016 | 5 | 60 | 2 | 409 |
| 2017 | 7 | 91 | 2 | 415 |
| 2018 | 8 | 103 | 0 | 537 |
| 2019 | 3 | 112 | 0 | 618 |
| 2020 | 2 | — | 0 | 631 |
| 2021 | 6 | 119 | 2 (2) | 734 |
| 2022 | 6 | 69 | 2 (2) | 566 |
| 2023 | 4 | 104 | 1 | 574 |
| 2024 | 3 | 41 | 2 | 677 |
| 2025 | 3 | 46 | 0 | 677 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.
The Auryon™ Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233668 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233668: Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233668
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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