510(k) · Cleared
ClearedAtb All-Terrain Balloon 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 Apr 2, 2004 as substantially equivalent to K022552 (Cook, Inc., 2002) and 4 other predicates after a 109-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Apr 2, 2004
- Review
- 109 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K970299 (1997). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK970299 Jupiter Pta Catheters (Various)Cordis Corp. · 1997
- 1 generation backK983055 RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20…Guidant Corp. · 1998
- This deviceK033875 Atb All-Terrain Balloon Pta Dilatation CatheterCook, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK113300 Atb Advance Pta Dilatation CatheterCook, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K113300Atb Advance Pta Dilatation CatheterCook, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970299 | Jupiter Pta Catheters (Various) | Cordis Corp. | 1997 | — |
| −1 | K983055 | RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20… | Guidant Corp. | 1998 | — |
| 0 (this device) | K033875 | Atb All-Terrain Balloon Pta Dilatation Catheter | Cook, Inc. | 2004 | — |
| +1 | K113300 | Atb Advance Pta Dilatation Catheter | Cook, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (5)
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 |
|---|---|---|---|
| * | K022552 | Atb All-Terrain Balloon Pta Dilatation CatheterSummary page 1…eter is similar to many devices in commercial distribution for dilatation and stent deployment. These devices include the ATB All-Terrain PTA Dilatation Catheter, D.C.#K022552, K023504, K031766 and K032931 and the RX Viatrac 14 Peripheral Dilatation Catheter, D.C.#K983055. The similar indications for… | 2002 |
| * | K023504 | Modification to Atb All-Terrain Balloon Pta Dilatation CatheterSummary page 1…imilar to many devices in commercial distribution for dilatation and stent deployment. These devices include the ATB All-Terrain PTA Dilatation Catheter, D.C.#K022552, K023504, K031766 and K032931 and the RX Viatrac 14 Peripheral Dilatation Catheter, D.C.#K983055. The similar indications for use and t… | 2002 |
| * | K031766 | Atb All-Terrain Balloon Pta Dilatation CatheterSummary page 1…many devices in commercial distribution for dilatation and stent deployment. These devices include the ATB All-Terrain PTA Dilatation Catheter, D.C.#K022552, K023504, K031766 and K032931 and the RX Viatrac 14 Peripheral Dilatation Catheter, D.C.#K983055. The similar indications for use and technologi… | 2003 |
| * | K032931 | Pta Balloon CatheterSummary page 1…in commercial distribution for dilatation and stent deployment. These devices include the ATB All-Terrain PTA Dilatation Catheter, D.C.#K022552, K023504, K031766 and K032931 and the RX Viatrac 14 Peripheral Dilatation Catheter, D.C.#K983055. The similar indications for use and technological character… | 2003 |
| * | K983055 | RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20…Summary page 1…hese devices include the ATB All-Terrain PTA Dilatation Catheter, D.C.#K022552, K023504, K031766 and K032931 and the RX Viatrac 14 Peripheral Dilatation Catheter, D.C.#K983055. The similar indications for use and technological characteristics of the ATB All- TerrainTM Balloon PTA Dilatation Catheter a… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113300 | Atb Advance Pta Dilatation Catheter | 2011 | 0 |
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 7 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K113300 (Cook, Inc., 2011) has gone furthest, with 0 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 All-Terrain Balloon 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/K033875 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033875: Atb All-Terrain Balloon Pta 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/K033875
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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