510(k) · Cleared
ClearedEagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imperative Care, Inc. · DQY Catheter, Percutaneous
Cleared on Aug 8, 2018 as substantially equivalent to K111380 (Penumbra, Inc., 2011) and 2 other predicates after a 198-day review. Its family tree reaches back 6 generations to 2001. 2 of the 39 devices in its family, counting itself, have a Class I recall. 27 later devices descend from it.
- Decided
- Aug 8, 2018
- Review
- 198 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K010954 (2001). 11 ancestors in all, the oldest K010853 (2001). 27 later devices descend from it, 3 citing it directly. 2 of the 39 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 5 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 4 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- 3 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- 2 generations backK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
- 1 generation backK111380 Neuron Max SystemPenumbra, Inc. · 2011
- This deviceK180169 EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths…Imperative Care, Inc. · 2018
- Descendant · cites it directly · 17 of its ownK203764 TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM…Imperative Care, Inc. · 2021
- Descendant · cites it directly · 8 of its ownK200121 Route 92 Medical 088 Access System, 110 cmRoute 92 Medical, Inc. · 2020
- Descendant · 2 generations on · 6 of its ownK214048 Millipede 088 Access CatheterPerfuze, Ltd. · 2022
- Descendant · cites it directly · 6 of its ownK212224 TracStar LDP Large Distal Platform; Zoom 88 Large Distal PlatformImperative Care, Inc. · 2021
- Descendant · 3 generations on · 5 of its ownK231802 Millipede 088 Access CatheterPerfuze, Ltd. · 2023
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 27 · See all- K203764TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal…Imperative Care, Inc. · 2021 · cites it directly17descendants
- K200121Route 92 Medical 088 Access System, 110 cmRoute 92 Medical, Inc. · 2020 · cites it directly8descendants
- K214048Millipede 088 Access CatheterPerfuze, Ltd. · 2022 · 2 generations on6descendants
- K212224TracStar LDP Large Distal Platform; Zoom 88 Large Distal PlatformImperative Care, Inc. · 2021 · cites it directly6descendants
- K231802Millipede 088 Access CatheterPerfuze, Ltd. · 2023 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −5 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −4 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| −3 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| −2 | K082290 | Neuron Delivery Catheter 070 | Penumbra, Inc. | 2008 | 1 |
| −1 | K111380 | Neuron Max System | Penumbra, Inc. | 2011 | — |
| 0 (this device) | K180169 | EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay… | Imperative Care, Inc. | 2018 | — |
| +1 | K203764 | TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large… | Imperative Care, Inc. | 2021 | — |
| +1 | K200121 | Route 92 Medical 088 Access System, 110 cm | Route 92 Medical, Inc. | 2020 | — |
| +2 | K214048 | Millipede 088 Access Catheter | Perfuze, Ltd. | 2022 | — |
| +1 | K212224 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform | Imperative Care, Inc. | 2021 | — |
| +3 | K231802 | Millipede 088 Access Catheter | Perfuze, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 3 | 1 |
| 2021 | 3 | 0 |
| 2022 | 3 | 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? (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 |
|---|---|---|---|
| * | K111380 | Neuron Max SystemSummary page 4…y Predicate Device Primary Proprietary Name: Neuron Max System Manufacturer: Penumbra Inc. 510(k) #'s: K111380 Common/Usual Name: Guide Sheath Classification Name: Catheter, Percutaneous Product Code:… | 2011 |
| * | K150107 | Arc Intracranial Support Catheter, Arc Mini Intracranial Support CatheterSummary page 4…Arc & Arc Mini Intracranial Support Catheter Manufacturer: Micro Therapeutics, Inc. Dba Ev3 Neurovascular 510(k) #: K150107 Common/Usual Name: Guide Catheter Classification Name: Catheter, Percutaneous Product Code:… | 2015 |
| * | K161152 | Navien Intracranial Support CatheterSummary page 4…Navien Intracranial Support Catheter Manufacturer: Micro Therapeutics, Inc. Dba Ev3 Neurovascular 510(k) #: K161152 Common/Usual Name: Guide Catheter Classification Name: Catheter, Percutaneous Product Code:… | 2016 |
What descends from it? (27)
See all 273 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 · 3 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 · 4 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 6 of the 11 ancestors have a recall of any class.
- Of its descendants, K203764 (Imperative Care, Inc., 2021) has gone furthest, with 17 descendants of its own.
- 9 other devices also cite its predicate K111380.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 EagleRay Long Sheath and EagleRay Access Catheter are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180169 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180169: EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180169
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