510(k) · Cleared
ClearedTotal Across
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DQY Catheter, Percutaneous
Cleared on Mar 26, 2014 as substantially equivalent to K082561 (Spectranetics Corp., 2008) and 2 other predicates after a 128-day review. Its family tree reaches back 7 generations to 1994. 2 later devices descend from it.
- Decided
- Mar 26, 2014
- Review
- 128 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K935425 (1994). 14 ancestors in all, the oldest K863137 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
- 6 generations backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
- 5 generations backK022138 Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002
- 4 generations backK033678 Spectranetics Quick Cross Catheters, Models 518-032, 518-033…Spectranetics Corp. · 2004
- 3 generations backK072750 Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and…Spectranetics Corp. · 2007
- 2 generations backK082561 Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp. · 2008
- 1 generation backK092396 Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp. · 2009
- This deviceK133539 Total AcrossMedtronic Vascular · 2014
- Descendant · cites it directly · 0 of its ownK183305 Crossing Support CatheterTractus Vascular, LLC · 2019
- Descendant · cites it directly · 0 of its ownK180889 Tractus Crossing Support CatheterTractus Vascular, LLC · 2018
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 | K935425 | Metronic Buchbinder Envoy Percutaneous Catheters | Medtronics Interventional Vascular | 1994 | — |
| −6 | K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018… | Spectranetics Corp. | 1999 | — |
| −5 | K022138 | Spectranetics 0.035 Support Catheter, Model 518-028 | Spectranetics Corp. | 2002 | — |
| −4 | K033678 | Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035… | Spectranetics Corp. | 2004 | — |
| −3 | K072750 | Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066 | Spectranetics Corp. | 2007 | — |
| −2 | K082561 | Spectranetics Quick-Cross Extreme Support Catheters | Spectranetics Corp. | 2008 | — |
| −1 | K092396 | Spectranetics Quick Cross Extreme Support Catheters | Spectranetics Corp. | 2009 | — |
| 0 (this device) | K133539 | Total Across | Medtronic Vascular | 2014 | — |
| +1 | K183305 | Crossing Support Catheter | Tractus Vascular, LLC | 2019 | — |
| +1 | K180889 | Tractus Crossing Support Catheter | Tractus Vascular, LLC | 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 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K082561 | Spectranetics Quick-Cross Extreme Support CathetersSummary page 2…K133539 p. 2of 44 Predicate Devices a Quick Cross® Extreme Support Catheter (K082561 SE- December 10 'h, 2008 and K092396 SE- September 4t1h 2009) * SeekerTh Crossing Support Catheter (K103367 SE- December 8 1h,… | 2008 |
| * | K092396 | Spectranetics Quick Cross Extreme Support CathetersSummary page 2…p. 2of 44 Predicate Devices a Quick Cross® Extreme Support Catheter (K082561 SE- December 10 'h, 2008 and K092396 SE- September 4t1h 2009) * SeekerTh Crossing Support Catheter (K103367 SE- December 8 1h, 2010) Device Description The TOTAL a… | 2009 |
| * | K103367 | Seeker Crossing Support CatheterSummary page 2…Predicate Devices a Quick Cross® Extreme Support Catheter (K082561 SE- December 10 'h, 2008 and K092396 SE- September 4t1h 2009) * SeekerTh Crossing Support Catheter (K103367 SE- December 8 1h, 2010) Device Description The TOTAL across is an over the wire (OTW) single lumen catheter composed of a spira… | 2010 |
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 20 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K183305 (Tractus Vascular, LLC, 2019) has gone furthest, with 0 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. 2014, 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 TOTAL across crossing support catheter is intended to guide and support a guidewire during the access of peripheral arteries, allow for wire exchanges, and provide a conduit for the infusion of saline solutions or diagnostic contrast agents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133539: Total Across.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133539
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