510(k) · Cleared
Recalled · Class II · 2013Supercross Microcatheter (130 CM), Supercross Microcatheter (150 CM) Model 5300, 5301
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · DQY Catheter, Percutaneous
Cleared on Dec 16, 2010 as substantially equivalent to K091345 (Vascular Solutions, Inc., 2009) after a 188-day review. Its family tree reaches back 7 generations to 2000. 1 of the 21 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled once.
- Decided
- Dec 16, 2010
- Review
- 188 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001992 (2000). 16 ancestors in all, the oldest K935425 (1994). 4 later devices descend from it, 3 citing it directly. 1 of the 21 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 6 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
- 5 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
- 4 generations backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
- 3 generations backK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
- 2 generations backK070372 Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support…Vascular Solutions, Inc. · 2007
- 1 generation backK091345 Gopher Gold Catheter, Model 5620Vascular Solutions, Inc. · 2009
- This deviceK101659 Supercross Microcatheter (130 CM), Supercross Microcatheter (150 CM)…Vascular Solutions, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK211240 ViperCross Support CathetersCardiovascular Systems, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK212725 ViperCross Support CathetersCardiovascular Systems, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK210647 SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT…Vascular Solutions, LLC · 2021
- Descendant · cites it directly · 0 of its ownK120707 Switch-IT CatheterVascular Solutions, Inc. · 2012
Class I recalls in this family
- K060327 Vascular Solutions Twin-Pass Dual Access…3 generations back · 2006
Most influential descendants
Showing 4 of 4 · See all- K211240ViperCross Support CathetersCardiovascular Systems, Inc. · 2021 · cites it directly1descendant
- K212725ViperCross Support CathetersCardiovascular Systems, Inc. · 2021 · 2 generations on0descendants
- K210647SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheterVascular Solutions, LLC · 2021 · cites it directly0descendants
- K120707Switch-IT CatheterVascular Solutions, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001992 | Ilt 0.014 Catheter, Model C114NL2 | Intra Luminal Therapeutics, Inc. | 2000 | — |
| −6 | K012169 | Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing… | Intra Luminal Therapeutics, Inc. | 2001 | — |
| −5 | K030984 | Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14… | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −4 | K032660 | Xtrak Support Catheter | Xtrak Medical, Inc. | 2003 | — |
| −3 | K051772 | Asahi Tornus Support Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| −2 | K070372 | Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model… | Vascular Solutions, Inc. | 2007 | — |
| −1 | K091345 | Gopher Gold Catheter, Model 5620 | Vascular Solutions, Inc. | 2009 | — |
| 0 (this device) | K101659 | Supercross Microcatheter (130 CM), Supercross Microcatheter (150 CM) Model… | Vascular Solutions, Inc. | 2010 | — |
| +1 | K211240 | ViperCross Support Catheters | Cardiovascular Systems, Inc. | 2021 | — |
| +2 | K212725 | ViperCross Support Catheters | Cardiovascular Systems, Inc. | 2021 | — |
| +1 | K210647 | SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT… | Vascular Solutions, LLC | 2021 | — |
| +1 | K120707 | Switch-IT Catheter | Vascular Solutions, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2021 | 3 | 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? (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 |
|---|---|---|---|
| * | K091345 | Gopher Gold Catheter, Model 5620Summary page 1…on / Usual Name microcatheter Classification Name 21 CFR 870.1250, Catheter, Percutaneous Predicate Device Gopher' m Gold catheter (K091345 - Vascular Solutions, Inc.) Device Description The SuperCross'" microcatheter (SuperCross) is a single-lumen catheter designe… | 2009 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 29, 2013 | Class II | Z-0868-2013 | Material/Component Contamination | Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed during in-house testing. |
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.
- K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · 3 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 16 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K211240 (Cardiovascular Systems, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K091345.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101659: Supercross Microcatheter (130 CM), Supercross Microcatheter (150 CM) Model 5300, 5301.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101659
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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