510(k) · Cleared
ClearedArc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics Inc Dba Ev3 Neurovascular · DQY Catheter, Percutaneous
Cleared on Jul 29, 2015 as substantially equivalent to K110055 (Reverse Medical Corporation, 2011) after a 190-day review. Its family tree reaches back 1 generation to 2011. 2 of the 31 devices in its family, counting itself, have a Class I recall. 29 later devices descend from it.
- Decided
- Jul 29, 2015
- Review
- 190 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K110055 (2011). 29 later devices descend from it, 2 citing it directly. 2 of the 31 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK110055 Reverse Medical Reflex Guide CatheterReverse Medical Corporation · 2011
- This deviceK150107 Arc Intracranial Support Catheter, Arc Mini Intracranial Support…Micro Therapeutics Inc Dba Ev3 Neurovascular · 2015
- Descendant · cites it directly · 27 of its ownK180169 EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths…Imperative Care, Inc. · 2018
- Descendant · 2 generations on · 17 of its ownK203764 TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM…Imperative Care, Inc. · 2021
- Descendant · 2 generations on · 8 of its ownK200121 Route 92 Medical 088 Access System, 110 cmRoute 92 Medical, Inc. · 2020
- Descendant · 3 generations on · 6 of its ownK214048 Millipede 088 Access CatheterPerfuze, Ltd. · 2022
- Descendant · 2 generations on · 6 of its ownK212224 TracStar LDP Large Distal Platform; Zoom 88 Large Distal PlatformImperative Care, Inc. · 2021
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 29 · See all- K180169EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access…Imperative Care, Inc. · 2018 · cites it directly27descendants
- K203764TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal…Imperative Care, Inc. · 2021 · 2 generations on17descendants
- K200121Route 92 Medical 088 Access System, 110 cmRoute 92 Medical, Inc. · 2020 · 2 generations on8descendants
- K214048Millipede 088 Access CatheterPerfuze, Ltd. · 2022 · 3 generations on6descendants
- K212224TracStar LDP Large Distal Platform; Zoom 88 Large Distal PlatformImperative Care, Inc. · 2021 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K110055 | Reverse Medical Reflex Guide Catheter | Reverse Medical Corporation | 2011 | — |
| 0 (this device) | K150107 | Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter | Micro Therapeutics Inc Dba Ev3 Neurovascular | 2015 | — |
| +1 | K180169 | EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay… | Imperative Care, Inc. | 2018 | — |
| +2 | K203764 | TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large… | Imperative Care, Inc. | 2021 | — |
| +2 | K200121 | Route 92 Medical 088 Access System, 110 cm | Route 92 Medical, Inc. | 2020 | — |
| +3 | K214048 | Millipede 088 Access Catheter | Perfuze, Ltd. | 2022 | — |
| +2 | K212224 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform | Imperative Care, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 3 | 1 |
| 2021 | 3 | 0 |
| 2022 | 4 | 1 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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.
2 devices in this family have 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 |
|---|---|---|---|
| * | K110055 | Reverse Medical Reflex Guide CatheterSummary page 4…aneous Device: Classification of 21 CFR 870.1250 – Class II Device: Product Code: DQY Predicate Device: ReFlex™ Guide Catheter, 510(k)#: K110055 Performance Data: The following bench testing was performed in support of the Arc™ and Arc™… | 2011 |
What descends from it? (29)
See all 292 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
- K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K222743Route 92 Medical Full Length 070 Access SystemRoute 92 Medical, Inc. · 2022 · 5 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are indicated for the introduction of interventional devices into the peripheral and neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150107 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150107: Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150107
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