510(k) · Cleared
ClearedReverse Medical Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reverse Medical Corporation · DQY Catheter, Percutaneous
Cleared on Oct 11, 2013 as substantially equivalent to K110813 (MicroVention, Inc., 2011) and 2 other predicates after a 197-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Oct 11, 2013
- Review
- 197 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K960806 (1996). 12 ancestors in all, the oldest K925813 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 5 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 4 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- 3 generations backK083343 Headway 17 MicrocatheterMicroVention, Inc. · 2008
- 2 generations backK093160 Headway 21 Microcatheter, Model: MC212150SMicroVention, Inc. · 2009
- 1 generation backK110813 Headway 27 MicrocatheterMicroVention, Inc. · 2011
- This deviceK130858 Reverse Medical MicrocatheterReverse Medical Corporation · 2013
- Descendant · cites it directly · 0 of its ownK171268 Reverse 021 Micro Catheter, Reverse 027 Micro CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2017
Most influential descendants
Showing 1 of 1 · See all- K171268Reverse 021 Micro Catheter, Reverse 027 Micro CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −5 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −4 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| −3 | K083343 | Headway 17 Microcatheter | MicroVention, Inc. | 2008 | — |
| −2 | K093160 | Headway 21 Microcatheter, Model: MC212150S | MicroVention, Inc. | 2009 | — |
| −1 | K110813 | Headway 27 Microcatheter | MicroVention, Inc. | 2011 | — |
| 0 (this device) | K130858 | Reverse Medical Microcatheter | Reverse Medical Corporation | 2013 | — |
| +1 | K171268 | Reverse 021 Micro Catheter, Reverse 027 Micro Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K110813 | Headway 27 MicrocatheterSummary page 1…(City, State) Number Headway M 27 Microcatheter MicroVention, Inc. K110813 Tustin, CA ExceisiorO XT-27'M Microcatheter Stryker Neurovascular… | 2011 |
| * | K113778 | Excelsior XT-27 MicrocatheterSummary page 1…K110813 Tustin, CA ExceisiorO XT-27'M Microcatheter Stryker Neurovascular K113778 Fremont, CA Rees eia icoahtr01-Reverse Medical Corp… | 2012 |
| * | K122684 | Reverse Medical MicrocatheterSummary page 1…113778 Fremont, CA Rees eia icoahtr01-Reverse Medical Corp. K122684 Revese edial icroathter021 Irvine, CA 5.7 Device Description The Reverse Medical… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171268 | Reverse 021 Micro Catheter, Reverse 027 Micro Catheter | 2017 | 0 |
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 17 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K171268 (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K110813.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Reverse Medical Microcatheter-027 is intended for use in neuro, peripheral and coronary vasculature for the infusion of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130858: Reverse Medical Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130858
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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