510(k) Report

510(k) · Cleared

Cleared

Reliant Stent Graft Balloon Catheter

K050038510(k) TraditionalCleared Apr 13, 200596-day reviewClass II21 CFR 870.1250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Endovascular Innovations · DQY Catheter, Percutaneous

Cleared on Apr 13, 2005 as substantially equivalent to K032869 (Cook, Inc., 2003) and 2 other predicates after a 96-day review. Its family tree reaches back 2 generations to 2001. 11 later devices descend from it.

Decided
Apr 13, 2005
Review
96 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K003495 (2001). 3 ancestors in all. 11 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2011: 1 descendant cleared2009: 1 descendant cleared2008: 1 descendant cleared2025: 2 descendants cleared2020: 1 descendant cleared2012: 3 descendants cleared2013: 1 descendant cleared2018: 1 descendant clearedK003495 · Ancure Lliac Balloon Catheter · Guidant Cardiac and Vascular Surgery · 2001K032869 · Cook Coda Balloon Catheter · Cook, Inc. · 2003200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 7 descendants3 generations forward: 1 descendant K032869 · Cook Coda Balloon Catheter · Cook, Inc. · 2003K003495 · Ancure Lliac Balloon Catheter · Guidant Cardiac and Vascular Surgery · 20010
  1. Root · 2 generations backK003495 Ancure Lliac Balloon CatheterGuidant Cardiac and Vascular Surgery · 2001
  2. 1 generation backK032869 Cook Coda Balloon CatheterCook, Inc. · 2003
  3. This deviceK050038 Reliant Stent Graft Balloon CatheterMedtronic Endovascular Innovations · 2005
  4. Descendant · cites it directly · 3 of its ownK110891 The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive…LeMaitre Vascular, Inc. · 2011
  5. Descendant · cites it directly · 3 of its ownK091624 Stent Graft Balloon CatheterVia Biomedical, Inc. · 2009
  6. Descendant · 2 generations on · 2 of its ownK121839 Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 2012
  7. Descendant · 2 generations on · 2 of its ownK120381 Q50 Plus Stent Graft Balloon CatheterQxmedical, LLC · 2012
  8. Descendant · cites it directly · 2 of its ownK081799 Gore Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc. · 2008

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12011: 12012: 32013: 12018: 12020: 12025: 2
2008high 3 (2012) · low 0 (2010)2026

Most influential descendants

Showing 5 of 11 · See all
  • K110891The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 2011 · cites it directly3descendants
  • K091624Stent Graft Balloon CatheterVia Biomedical, Inc. · 2009 · cites it directly3descendants
  • K121839Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 2012 · 2 generations on2descendants
  • K120381Q50 Plus Stent Graft Balloon CatheterQxmedical, LLC · 2012 · 2 generations on2descendants
  • K081799Gore Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc. · 2008 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K003495Ancure Lliac Balloon CatheterGuidant Cardiac and Vascular Surgery2001—
−1K032869Cook Coda Balloon CatheterCook, Inc.2003—
0 (this device)K050038Reliant Stent Graft Balloon CatheterMedtronic Endovascular Innovations2005—
+1K110891The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling…LeMaitre Vascular, Inc.2011—
+1K091624Stent Graft Balloon CatheterVia Biomedical, Inc.2009—
+2K121839Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc.2012—
+2K120381Q50 Plus Stent Graft Balloon CatheterQxmedical, LLC2012—
+1K081799Gore Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201110
201230
201310
201810
202010
202520
FIG. 1 — Lineage of K050038, 2001–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K032869Cook Coda Balloon Catheter
Summary page 1
…atheter Common Name: Balloon Catheter Classification Percutaneous Catheter Name: Predicate Devices: The CODA Balloon Catheter (K032869) manufactured by Cook Incorporated (vessel occlusion and expansion of v…
Cook, Inc.2003—
*K003495Ancure Lliac Balloon Catheter
Summary page 1
…scular prosthesis, product code DQY), and was cleared by FDA on November 19, 2003. The Iliac Balloon Catheter (K003495) manufactured by Guidant Corporation (prosthesis expansion, product code…
Guidant Cardiac and Vascular Surgery2001—
*K002286Ldob Occlusion Balloon Catheter
Summary page 1
…product code DQY), and was cleared by FDA on February 7, 200 1. The Large Diameter Occlusion Balloon Catheter (K002286) manufactured by Cook Incorporated (vessel occlusion, product code MJN)…
Cook, Inc.2001—

Also cleared against K032869: 8 other devices →

What descends from it? (11)

See all 11

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110891The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc.20113
K091624Stent Graft Balloon CatheterVia Biomedical, Inc.20093
K081799Gore Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc.20082

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 4 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K110891 (LeMaitre Vascular, Inc., 2011) has gone furthest, with 3 descendants of its own.
  • 8 other devices also cite its predicate K032869.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

The Reliant 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.

Also cleared against K032869

8 other devices cite the same predicate.

  • K151821ER-REBOA CatheterPryor Medical Devices, Inc. · 2015
  • K150970Coda LP Balloon CatheterCook Incorporated · 2015
  • K122917Coda Balloon CatheterCook, Inc. · 2013
  • K110891The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 2011
  • K101877Occlusion Balloon Catheter Model ObcCook, Inc. · 2010
  • K091624Stent Graft Balloon CatheterVia Biomedical, Inc. · 2009

Recent decisions in DQY

The DQY category page

  • K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc. · 2026
  • K260559NHanceITIMDS Operation B.V. · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
  • K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
  • K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC · 2026

https://510kreport.com/device/K050038 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050038: Reliant Stent Graft Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050038

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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