510(k) · Cleared
ClearedStent Graft Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Via Biomedical, Inc. · DQY Catheter, Percutaneous
Cleared on Oct 15, 2009 as substantially equivalent to K050038 (Medtronic Endovascular Innovations, 2005) and 2 other predicates after a 134-day review. Its family tree reaches back 3 generations to 2001. 3 later devices descend from it.
- Decided
- Oct 15, 2009
- Review
- 134 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K003495 (2001). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK003495 Ancure Lliac Balloon CatheterGuidant Cardiac and Vascular Surgery · 2001
- 2 generations backK032869 Cook Coda Balloon CatheterCook, Inc. · 2003
- 1 generation backK050038 Reliant Stent Graft Balloon CatheterMedtronic Endovascular Innovations · 2005
- This deviceK091624 Stent Graft Balloon CatheterVia Biomedical, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK120381 Q50 Plus Stent Graft Balloon CatheterQxmedical, LLC · 2012
- Descendant · cites it directly · 0 of its ownK192786 Gatekeeper Balloon CatheterArch Catheter, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK172567 GORE Molding and Occlusion Balloon CatheterW. L. Gore and Associates, Inc. · 2018 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K120381Q50 Plus Stent Graft Balloon CatheterQxmedical, LLC · 2012 · cites it directly2descendants
- K192786Gatekeeper Balloon CatheterArch Catheter, LLC · 2020 · cites it directly0descendants
- K172567GORE Molding and Occlusion Balloon CatheterW. L. Gore and Associates, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003495 | Ancure Lliac Balloon Catheter | Guidant Cardiac and Vascular Surgery | 2001 | — |
| −2 | K032869 | Cook Coda Balloon Catheter | Cook, Inc. | 2003 | — |
| −1 | K050038 | Reliant Stent Graft Balloon Catheter | Medtronic Endovascular Innovations | 2005 | — |
| 0 (this device) | K091624 | Stent Graft Balloon Catheter | Via Biomedical, Inc. | 2009 | — |
| +1 | K120381 | Q50 Plus Stent Graft Balloon Catheter | Qxmedical, LLC | 2012 | — |
| +1 | K192786 | Gatekeeper Balloon Catheter | Arch Catheter, LLC | 2020 | — |
| +2 | K172567 | GORE Molding and Occlusion Balloon Catheter | W. L. Gore and Associates, Inc. | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K050038 | Reliant Stent Graft Balloon CatheterSummary page 1…Predicate Device Manufacturer 510(k) Status Reliant Stent Graft Balloon Medtronic, Inc. K050038 Catheter Coda Balloon Catheter ICook, Inc. K032869 Equalizer Balloon Cathet… | 2005 |
| * | K032869 | Cook Coda Balloon CatheterSummary page 1…Reliant Stent Graft Balloon Medtronic, Inc. K050038 Catheter Coda Balloon Catheter ICook, Inc. K032869 Equalizer Balloon Catheter Boston Scientific, Inc. K021721 May 29,2009… | 2003 |
| * | K021721 | Equalizer Balloon CatheterSummary page 1…Catheter Coda Balloon Catheter ICook, Inc. K032869 Equalizer Balloon Catheter Boston Scientific, Inc. K021721 May 29,2009 000012 Via Bio… | 2002 |
What descends from it? (3)
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 8 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K120381 (Qxmedical, LLC, 2012) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K050038.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091624 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091624: Stent Graft Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091624
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