510(k) · Cleared
ClearedEdwards Peripheral Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DQY Catheter, Percutaneous
Cleared on Oct 2, 2003 as substantially equivalent to K023907 (Cordis Corp., 2002) and 1 other predicate after a 41-day review. Its family tree reaches back 2 generations to 2000. 48 later devices descend from it.
- Decided
- Oct 2, 2003
- Review
- 41 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K993720 (2000). 3 ancestors in all. 48 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK993720 Cordis Maxi LD Large Diameter Balloon Dilatation CatheterCordis Corp. · 2000
- 1 generation backK023907 Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis…Cordis Corp. · 2002
- This deviceK032587 Edwards Peripheral Dilatation CatheterEdwards Lifesciences, LLC · 2003
- Descendant · cites it directly · 47 of its ownK052149 Edwards Peripheral Dilation CatheterEdwards Lifesciences, LLC · 2005
- Descendant · 2 generations on · 44 of its ownK083657 Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 36 of its ownK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010
- Descendant · 4 generations on · 29 of its ownK112182 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
- Descendant · 5 generations on · 28 of its ownK122685 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2013
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K052149Edwards Peripheral Dilation CatheterEdwards Lifesciences, LLC · 2005 · cites it directly47descendants
- K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · 2 generations on44descendants
- K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010 · 3 generations on36descendants
- K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011 · 4 generations on29descendants
- K122685Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2013 · 5 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993720 | Cordis Maxi LD Large Diameter Balloon Dilatation Catheter | Cordis Corp. | 2000 | — |
| −1 | K023907 | Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis Maxi LD Pta… | Cordis Corp. | 2002 | — |
| 0 (this device) | K032587 | Edwards Peripheral Dilatation Catheter | Edwards Lifesciences, LLC | 2003 | — |
| +1 | K052149 | Edwards Peripheral Dilation Catheter | Edwards Lifesciences, LLC | 2005 | — |
| +2 | K083657 | Conquest Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2008 | 2 |
| +3 | K103459 | Vascutrak Pta Dilatation Catheter | C.R. Bard, Inc. | 2010 | — |
| +4 | K112182 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2011 | — |
| +5 | K122685 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 4 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K023907 | Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis Maxi LD Pta Balloon…Summary page 1…al dilatation catheter 6. Device Classification Name: Catheter, percutaneous (DQY), Class II 7. Predicate Devices: Cordis MAXI LD Esophageal Dilator (K023907) Guidant AGILTRACTM035 Peripheral Dilatation Catheter (K023320) Edwards Lifes… | 2002 |
| * | K023320 | Agiltrac .035 Peripheral Dilatation CatheterSummary page 1…heter, percutaneous (DQY), Class II 7. Predicate Devices: Cordis MAXI LD Esophageal Dilator (K023907) Guidant AGILTRACTM035 Peripheral Dilatation Catheter (K023320) Edwards Lifesciences LLC One Edwards Way. I… | 2002 |
What descends from it? (48)
See all 481 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052149 | Edwards Peripheral Dilation Catheter | 2005 | 47 |
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 3 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K052149 (Edwards Lifesciences, LLC, 2005) has gone furthest, with 47 descendants of its own.
- 1 other device also cites its predicate K023907.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Edwards Peripheral Dilatation Catheter is intended to:
dilate stenoses in 10 - 14mm peripheral arteries,
treat obstructive lesions of native or synthetic A-V fistulae and/or
re-expand endoluminal stent graft elements in the aorta and iliac arteries
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032587 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032587: Edwards Peripheral Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032587
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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