510(k) · Cleared
Recalled · 2007Atb Advance Pta Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · DQY Catheter, Percutaneous
Cleared on Aug 25, 2005 after a 28-day review. The FDA summary names no predicate by number. 1 of the 13 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it. It has been recalled once.
- Decided
- Aug 25, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 0
12 later devices descend from it, 2 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- This deviceK052036 Atb Advance Pta Dilatation CatheterCook, Inc. · 2005
- Descendant · cites it directly · 10 of its ownK090364 Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd. · 2010
- Descendant · 2 generations on · 5 of its ownK111750 Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta…Angioslide, Ltd. · 2011
- Descendant · 2 generations on · 4 of its ownK111010 Spiderfx Embolic Protection DeviceEv3, Inc. · 2011
- Descendant · 3 generations on · 3 of its ownK120805 Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2012
- Descendant · 3 generations on · 2 of its ownK180023 WirionGardia Medical, Ltd. · 2018
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K210282 WIRION Embolic Protection System5 generations on · 2021
Most influential descendants
Showing 5 of 12 · See all- K090364Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd. · 2010 · cites it directly10descendants
- K111750Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon Catheter…Angioslide, Ltd. · 2011 · 2 generations on5descendants
- K111010Spiderfx Embolic Protection DeviceEv3, Inc. · 2011 · 2 generations on4descendants
- K120805Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2012 · 3 generations on3descendants
- K180023WirionGardia Medical, Ltd. · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052036 | Atb Advance Pta Dilatation Catheter | Cook, Inc. | 2005 | — |
| +1 | K090364 | Extra Pta Balloon Catheter with Embolic Protection Feature | Angioslide, Ltd. | 2010 | — |
| +2 | K111750 | Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon… | Angioslide, Ltd. | 2011 | — |
| +2 | K111010 | Spiderfx Embolic Protection Device | Ev3, Inc. | 2011 | — |
| +3 | K120805 | Proteus Pta Balloon Catheter with Embolic Capture Feature | Angioslide, Ltd. | 2012 | — |
| +3 | K180023 | Wirion | Gardia Medical, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 1 |
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.
1 device in this family has 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?
The FDA summary names no predicate by number.
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 28, 2007 | Not classified | Z-0665-2007 | Other | Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0. |
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.
- K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K090364 (Angioslide, Ltd., 2010) has gone furthest, with 10 descendants of its own.
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?
For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ATB Advance PTA Dilatation Catheter is also intended for post-dilatation of balloon-expandable peripheral vascular stents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052036: Atb Advance Pta Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052036
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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