510(k) · Cleared
Recalled · Class II · 2020RA-308 Excimer Laser System, Excimer Laser Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ra Medical Systems,Inc · PDU Catheter For Crossing Total Occlusions
Cleared on May 24, 2017 as substantially equivalent to K040067 (Spectranetics Corp., 2004) after a 110-day review. Its family tree reaches back 7 generations to 1989. 2 later devices descend from it. It has been recalled 5 times.
- Decided
- May 24, 2017
- Review
- 110 days
- Class
- Class II
- Product code
- PDU
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 7 generations to K890505 (1989). 26 ancestors in all, the oldest K871011 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 6 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 5 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 4 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 3 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 2 generations backK031842 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2003
- 1 generation backK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
- This deviceK170349 RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc · 2017
- Descendant · cites it directly · 1 of its ownK210664 DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter…Ra Medical Systems,Inc · 2021
- Descendant · 2 generations on · 0 of its ownK220544 DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA…Ra Medical Systems,Inc · 2022
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 |
|---|---|---|---|---|---|
| −7 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −6 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −5 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −4 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −3 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −2 | K031842 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −1 | K040067 | Clirpath Excimer Laser Catheter | Spectranetics Corp. | 2004 | — |
| 0 (this device) | K170349 | RA-308 Excimer Laser System, Excimer Laser Catheter | Ra Medical Systems,Inc | 2017 | — |
| +1 | K210664 | DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) | Ra Medical Systems,Inc | 2021 | — |
| +2 | K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model… | Ra Medical Systems,Inc | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K040067 | Clirpath Excimer Laser CatheterSummary page 4…us catheter D. Device Class: Class II (per 870.1250 percutaneous catheter) E. Device Code: PDU Identification of Predicate Device Spectranetics CLiRpath Laser Catheters; K040067. Identification of Reference Devices Ra Medical EX-308; K062963 Spectranetics CVX-300; K052514 Device Description Ra Medical Syst… | 2004 |
| † | K062963 | Pharos Excimer Laser System, Model EX-308 | 2007 |
| † | K052514 | Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210664 | DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) | 2021 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 16, 2020 | Class II | Z-0569-2021 | Device Design | Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase. |
| Jul 24, 2020 | Class II | Z-0050-2021 | Device Design | Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury. |
| Jan 23, 2020 | Class II | Z-2497-2020 | Software design | A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient. |
| Sep 19, 2019 | Class II | Z-2006-2020 | Under Investigation by firm | The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently less than the labeled shelf life. |
| Feb 15, 2018 | Class II | Z-2218-2019 | Other | Lasers/Catheters did not calibrate during set-up prior to use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K210664 (Ra Medical Systems,Inc, 2021) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K040067.
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. 2017, 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 DABRA Laser System is indicated for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170349: RA-308 Excimer Laser System, Excimer Laser Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170349
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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