510(k) · Cleared
ClearedNaviCross 0.018
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Corporation · DQY Catheter, Percutaneous
Cleared on Mar 29, 2018 as substantially equivalent to K110540 (Terumo Medical Corp., 2011) after a 105-day review. Its family tree reaches back 8 generations to 1994. 2 later devices descend from it.
- Decided
- Mar 29, 2018
- Review
- 105 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K935425 (1994). 14 ancestors in all, the oldest K863137 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
- 7 generations backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
- 6 generations backK022138 Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002
- 5 generations backK033678 Spectranetics Quick Cross Catheters, Models 518-032, 518-033…Spectranetics Corp. · 2004
- 4 generations backK072750 Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and…Spectranetics Corp. · 2007
- 3 generations backK082561 Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp. · 2008
- 2 generations backK092396 Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp. · 2009
- 1 generation backK110540 Terumo Support CatheterTerumo Medical Corp. · 2011
- This deviceK173799 NaviCross 0.018Terumo Corporation · 2018
- Descendant · cites it directly · 0 of its ownK253361 Teleport Glide MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK220632 Boss Crossing Support CatheterMarvao Medical Devices, Ltd. · 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 |
|---|---|---|---|---|---|
| −8 | K935425 | Metronic Buchbinder Envoy Percutaneous Catheters | Medtronics Interventional Vascular | 1994 | — |
| −7 | K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018… | Spectranetics Corp. | 1999 | — |
| −6 | K022138 | Spectranetics 0.035 Support Catheter, Model 518-028 | Spectranetics Corp. | 2002 | — |
| −5 | K033678 | Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035… | Spectranetics Corp. | 2004 | — |
| −4 | K072750 | Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066 | Spectranetics Corp. | 2007 | — |
| −3 | K082561 | Spectranetics Quick-Cross Extreme Support Catheters | Spectranetics Corp. | 2008 | — |
| −2 | K092396 | Spectranetics Quick Cross Extreme Support Catheters | Spectranetics Corp. | 2009 | — |
| −1 | K110540 | Terumo Support Catheter | Terumo Medical Corp. | 2011 | — |
| 0 (this device) | K173799 | NaviCross 0.018 | Terumo Corporation | 2018 | — |
| +1 | K253361 | Teleport Glide Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2026 | — |
| +1 | K220632 | Boss Crossing Support Catheter | Marvao Medical Devices, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 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 |
|---|---|---|---|
| * | K110540 | Terumo Support CatheterSummary page 5…ct Code: DQY Classification: Class I C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed device to which substantial equivalence is claimed is: Predicate Device: K110540 — TERUMO SUPPORT CATHETER, manufactured by Ashitaka Factory of Terumo Corporation. Reference Devices: 1. K160884: CXI 0.018” su… | 2011 |
| † | K160884 | CXI Support Catheter | 2016 |
| † | K033678 | Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036… | 2004 |
| † | K122394 | Rubicon 18 Support Catheter | 2012 |
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 24 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K253361 (OrbusNeich Medical (Shenzhen) Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K110540.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The NaviCross 0.018" is intended to guide and support a guide wire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.
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/K173799 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173799: NaviCross 0.018.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173799
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