510(k) · Cleared
ClearedSpectranetics Quick Cross Extreme Support Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectranetics Corp. · DQY Catheter, Percutaneous
Cleared on Sep 4, 2009 as substantially equivalent to K082561 (Spectranetics Corp., 2008) and 1 other predicate after a 30-day review. Its family tree reaches back 6 generations to 1994. 13 later devices descend from it.
- Decided
- Sep 4, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K935425 (1994). 12 ancestors in all, the oldest K863137 (1986). 13 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
- 5 generations backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
- 4 generations backK022138 Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002
- 3 generations backK033678 Spectranetics Quick Cross Catheters, Models 518-032, 518-033…Spectranetics Corp. · 2004
- 2 generations backK072750 Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and…Spectranetics Corp. · 2007
- 1 generation backK082561 Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp. · 2008
- This deviceK092396 Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp. · 2009
- Descendant · cites it directly · 6 of its ownK110540 Terumo Support CatheterTerumo Medical Corp. · 2011
- Descendant · 2 generations on · 2 of its ownK173799 NaviCross 0.018Terumo Corporation · 2018
- Descendant · cites it directly · 2 of its ownK133539 Total AcrossMedtronic Vascular · 2014
- Descendant · 2 generations on · 1 of its ownK231044 R2P NavicrossTerumo Medical Corporation · 2023
- Descendant · 2 generations on · 1 of its ownK183000 ViperCath XC Peripheral Exchange CatheterCardiovascular Systems, Inc. · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K110540Terumo Support CatheterTerumo Medical Corp. · 2011 · cites it directly6descendants
- K173799NaviCross 0.018Terumo Corporation · 2018 · 2 generations on2descendants
- K133539Total AcrossMedtronic Vascular · 2014 · cites it directly2descendants
- K231044R2P NavicrossTerumo Medical Corporation · 2023 · 2 generations on1descendant
- K183000ViperCath XC Peripheral Exchange CatheterCardiovascular Systems, Inc. · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935425 | Metronic Buchbinder Envoy Percutaneous Catheters | Medtronics Interventional Vascular | 1994 | — |
| −5 | K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018… | Spectranetics Corp. | 1999 | — |
| −4 | K022138 | Spectranetics 0.035 Support Catheter, Model 518-028 | Spectranetics Corp. | 2002 | — |
| −3 | K033678 | Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035… | Spectranetics Corp. | 2004 | — |
| −2 | K072750 | Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066 | Spectranetics Corp. | 2007 | — |
| −1 | K082561 | Spectranetics Quick-Cross Extreme Support Catheters | Spectranetics Corp. | 2008 | — |
| 0 (this device) | K092396 | Spectranetics Quick Cross Extreme Support Catheters | Spectranetics Corp. | 2009 | — |
| +1 | K110540 | Terumo Support Catheter | Terumo Medical Corp. | 2011 | — |
| +2 | K173799 | NaviCross 0.018 | Terumo Corporation | 2018 | — |
| +1 | K133539 | Total Across | Medtronic Vascular | 2014 | — |
| +2 | K231044 | R2P Navicross | Terumo Medical Corporation | 2023 | — |
| +2 | K183000 | ViperCath XC Peripheral Exchange Catheter | Cardiovascular Systems, Inc. | 2018 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 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 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? (2)
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 |
|---|---|---|---|
| * | K082561 | Spectranetics Quick-Cross Extreme Support CathetersSummary page 1…Catheters Percutaneous Class: II Product Code: DQY Predicate Devices: Spectranetics Quick Cross®D Extreme Support Catheters K082561 and the Spectranetics Quick Cross Support 2 Catheters K072750 Device Description:The Spectranet… | 2008 |
| * | K072750 | Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066Summary page 1…s: Spectranetics Quick Cross®D Extreme Support Catheters K082561 and the Spectranetics Quick Cross Support 2 Catheters K072750 Device Description:The Spectranetics Quick-Cross® Extreme Support Catheters are intravascular catheters. These cath… | 2007 |
What descends from it? (13)
See all 136 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 15 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K110540 (Terumo Medical Corp., 2011) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K082561.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Quick-Cross® Extreme Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions 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/K092396 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092396: Spectranetics Quick Cross Extreme Support Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092396
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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