510(k) · Cleared
ClearedSpectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectranetics Corp. · DQY Catheter, Percutaneous
Cleared on Dec 4, 2007 as substantially equivalent to K991059 (Spectranetics Corp., 1999) and 2 other predicates after a 68-day review. Its family tree reaches back 4 generations to 1994. 1 of the 71 devices in its family, counting itself, has a Class I recall. 66 later devices descend from it.
- Decided
- Dec 4, 2007
- Review
- 68 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K935425 (1994). 66 later devices descend from it, 8 citing it directly. 1 of the 71 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
- 3 generations backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
- 2 generations backK022138 Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002
- 1 generation backK033678 Spectranetics Quick Cross Catheters, Models 518-032, 518-033…Spectranetics Corp. · 2004
- This deviceK072750 Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and…Spectranetics Corp. · 2007
- Descendant · cites it directly · 35 of its ownK082337 Minnie Support CatheterVascular Solutions, Inc. · 2009
- Descendant · cites it directly · 18 of its ownK082561 Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp. · 2008
- Descendant · 2 generations on · 14 of its ownK091750 Guideliner Catheter, Models 5571, 5572, 5573Vascular Solutions, Inc. · 2009
- Descendant · cites it directly · 13 of its ownK092396 Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp. · 2009
- Descendant · 3 generations on · 12 of its ownK112082 Guideliner V2 CatheterVascular Solutions, Inc. · 2011 · Recalled
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K141547 Wingman Extendable Tip Support Catheter4 generations on · 2014
Most influential descendants
Showing 5 of 66 · See all- K082337Minnie Support CatheterVascular Solutions, Inc. · 2009 · cites it directly35descendants
- K082561Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp. · 2008 · cites it directly18descendants
- K091750Guideliner Catheter, Models 5571, 5572, 5573Vascular Solutions, Inc. · 2009 · 2 generations on14descendants
- K092396Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp. · 2009 · cites it directly13descendants
- K112082Guideliner V2 CatheterVascular Solutions, Inc. · 2011 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935425 | Metronic Buchbinder Envoy Percutaneous Catheters | Medtronics Interventional Vascular | 1994 | — |
| −3 | K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018… | Spectranetics Corp. | 1999 | — |
| −2 | K022138 | Spectranetics 0.035 Support Catheter, Model 518-028 | Spectranetics Corp. | 2002 | — |
| −1 | K033678 | Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035… | Spectranetics Corp. | 2004 | — |
| 0 (this device) | K072750 | Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066 | Spectranetics Corp. | 2007 | — |
| +1 | K082337 | Minnie Support Catheter | Vascular Solutions, Inc. | 2009 | — |
| +1 | K082561 | Spectranetics Quick-Cross Extreme Support Catheters | Spectranetics Corp. | 2008 | — |
| +2 | K091750 | Guideliner Catheter, Models 5571, 5572, 5573 | Vascular Solutions, Inc. | 2009 | — |
| +1 | K092396 | Spectranetics Quick Cross Extreme Support Catheters | Spectranetics Corp. | 2009 | — |
| +3 | K112082 | Guideliner V2 Catheter | Vascular Solutions, Inc. | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 1 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 6 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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 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? (3)
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 |
|---|---|---|---|
| * | K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support…Summary page 1…, Percutaneous D. Device Class: Class 11(per 21 CIFR 870.1330) E. Device Code: DQY CLAIMED EQUIVALENCE Spectranetics; Quick-Cross Support2 Catheter Models: 0.01 4" (K991059), 0.035" (K0221 38), and modified 0.014"/0.035" (K033678) DEVICE DESCRIPTION Model number Wire compatibility Sh… | 1999 |
| * | K022138 | Spectranetics 0.035 Support Catheter, Model 518-028Summary page 1…Device Class: Class 11(per 21 CIFR 870.1330) E. Device Code: DQY CLAIMED EQUIVALENCE Spectranetics; Quick-Cross Support2 Catheter Models: 0.01 4" (K991059), 0.035" (K0221 38), and modified 0.014"/0.035" (K033678) DEVICE DESCRIPTION Model number Wire compatibility Sheath Compatibility… | 2002 |
| * | K033678 | Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036…Summary page 1….1330) E. Device Code: DQY CLAIMED EQUIVALENCE Spectranetics; Quick-Cross Support2 Catheter Models: 0.01 4" (K991059), 0.035" (K0221 38), and modified 0.014"/0.035" (K033678) DEVICE DESCRIPTION Model number Wire compatibility Sheath Compatibility Length 518-065 0.014"… | 2004 |
What descends from it? (66)
See all 668 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082337 | Minnie Support Catheter | 2009 | 35 |
| K082561 | Spectranetics Quick-Cross Extreme Support Catheters | 2008 | 18 |
| K092396 | Spectranetics Quick Cross Extreme Support Catheters | 2009 | 13 |
| K141649 | Spex Support Catheter | 2014 | 6 |
| K101479 | Wingman Extendable Tip Support Catheter | 2010 | 5 |
| K160848 | Wingman 18 Crossing Catheter | 2016 | 3 |
| K092299 | Trailblazer Support Catheter | 2009 | 2 |
| K233637 | Cordis BRITECROSS Support Catheter | 2024 | 0 |
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.
- K141547Wingman Extendable Tip Support CatheterReflow Medical · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K082337 (Vascular Solutions, Inc., 2009) has gone furthest, with 35 descendants of its own.
- 6 other devices also cite its predicate K991059.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Spectranetics Quick-Cross Support 2 Catheters are designed for use in
the vascular system. The catheters are intended to support a guide wire
during access to the vasculature, allow for exchange of guide wires, and
provide a conduit for the delivery of saline solutions or diagnostic contrast
agents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072750 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072750: Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072750
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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