510(k) · Cleared
ClearedValet Micro Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volcano Corporation · DQY Catheter, Percutaneous
Cleared on Jan 5, 2012 as substantially equivalent to K083127 (Asahi Intecc Co., Ltd., 2009) after a 174-day review. Its family tree reaches back 7 generations to 2000. 9 later devices descend from it.
- Decided
- Jan 5, 2012
- Review
- 174 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001992 (2000). 14 ancestors in all, the oldest K945904 (1995). 9 later devices descend from it, 2 citing it directly.
- 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 backK062885 Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007
- 1 generation backK083127 Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009
- This deviceK112035 Valet Micro CatheterVolcano Corporation · 2012
- Descendant · cites it directly · 6 of its ownK141649 Spex Support CatheterReflow Medical · 2014
- Descendant · 2 generations on · 5 of its ownK173662 speX Support CatheterReflow Medical, Inc. · 2017
- Descendant · 3 generations on · 2 of its ownK193012 speX Support CatheterReflow Medical · 2020
- Descendant · 4 generations on · 1 of its ownK201811 coraForce and coraFlex Support CathetersReflow Medical, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK200094 speX LP Support CatheterReflow Medical · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K141649Spex Support CatheterReflow Medical · 2014 · cites it directly6descendants
- K173662speX Support CatheterReflow Medical, Inc. · 2017 · 2 generations on5descendants
- K193012speX Support CatheterReflow Medical · 2020 · 3 generations on2descendants
- K201811coraForce and coraFlex Support CathetersReflow Medical, Inc. · 2020 · 4 generations on1descendant
- K200094speX LP Support CatheterReflow Medical · 2020 · 3 generations on1descendant
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 | K062885 | Stride Microcatheter | Asahi Intecc Co., Ltd. | 2007 | — |
| −1 | K083127 | Asahi Corsair Microcatheter | Asahi Intecc Co., Ltd. | 2009 | — |
| 0 (this device) | K112035 | Valet Micro Catheter | Volcano Corporation | 2012 | — |
| +1 | K141649 | Spex Support Catheter | Reflow Medical | 2014 | — |
| +2 | K173662 | speX Support Catheter | Reflow Medical, Inc. | 2017 | — |
| +3 | K193012 | speX Support Catheter | Reflow Medical | 2020 | — |
| +4 | K201811 | coraForce and coraFlex Support Catheters | Reflow Medical, Inc. | 2020 | — |
| +3 | K200094 | speX LP Support Catheter | Reflow Medical | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K083127 | Asahi Corsair MicrocatheterSummary page 1…21 CFR Part 870.1250 Class 11Device PREDICATE DEVICE: Asahi Corsair Microcatheter (K083127) DEVICE DESCRIPTION: The Valet TM Micro Catheter is a support catheter… | 2009 |
What descends from it? (9)
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 12 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K141649 (Reflow Medical, 2014) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K083127.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 ValetTM Micro Catheter is indicated for use as a conduit for the
exchange/support of guidewires in the peripheral and coronary
vasculatures. The ValeTM Micro Catheter is also indicated to infuse and
deliver saline and contrast agents. The Valetm Micro Catheter is not
intended for use in the neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112035: Valet Micro Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112035
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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