510(k) · Cleared
Recalled · Class II · 2019091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inneuroco, Inc. · DQY Catheter, Percutaneous
Cleared on Dec 6, 2017 as substantially equivalent to K152876 (Tni Manufacturing, Inc., 2016) after a 113-day review. Its family tree reaches back 7 generations to 2001. 2 later devices descend from it. It has been recalled once.
- Decided
- Dec 6, 2017
- Review
- 113 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K010954 (2001). 9 ancestors in all, the oldest K010853 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 6 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 5 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- 4 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- 3 generations backK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
- 2 generations backK111380 Neuron Max SystemPenumbra, Inc. · 2011
- 1 generation backK152876 Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or…Tni Manufacturing, Inc. · 2016 · Recalled
- This deviceK172468 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cmInneuroco, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK193034 AXS Infinity LS Plus Long SheathStryker Neurovascular · 2019
- Descendant · 2 generations on · 0 of its ownK241637 Echo Intracranial Base CatheterStryker Neurovascular · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −6 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −5 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| −4 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| −3 | K082290 | Neuron Delivery Catheter 070 | Penumbra, Inc. | 2008 | 1 |
| −2 | K111380 | Neuron Max System | Penumbra, Inc. | 2011 | — |
| −1 | K152876 | Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM | Tni Manufacturing, Inc. | 2016 | 1 |
| 0 (this device) | K172468 | 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm | Inneuroco, Inc. | 2017 | — |
| +1 | K193034 | AXS Infinity LS Plus Long Sheath | Stryker Neurovascular | 2019 | — |
| +2 | K241637 | Echo Intracranial Base Catheter | Stryker Neurovascular | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K152876 | Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CMSummary page 5…Name of Predicate Device Name of Manufacturer 510(k) Number AXS Infinity LS Stryker K152876 Device Description The InNeuroCo, Inc. 091 Long Sheath is a variable stiffness catheter that has a catheter shaft reinforced… | 2016 |
| † | K161262 | Super Distal Access (SDA) | 2016 |
| † | K171672 | 065 Zenith, 074 Zenith | 2017 |
| † | K152202 | Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193034 | AXS Infinity LS Plus Long Sheath | 2019 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 18, 2019 | Class II | Z-1708-2019 | Device Design | A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 9 ancestors have a recall of any class.
- Of its descendants, K193034 (Stryker Neurovascular, 2019) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K152876.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 091 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro
vasulature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172468: 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172468
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