510(k) · Cleared
ClearedPasseo-35 Pta Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · DQY Catheter, Percutaneous
Cleared on Nov 3, 2008 as substantially equivalent to K033217 (Biotronik, Inc., 2003) and 2 other predicates after a 33-day review. Its family tree reaches back 4 generations to 2000. 5 later devices descend from it.
- Decided
- Nov 3, 2008
- Review
- 33 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K000101 (2000). 7 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK000101 RX Viatrac 14 Peripheral Dilatation CatheterGuidant Corp. · 2000
- 3 generations backK020854 Modification to Fox Pta CatheterJomed AG · 2002
- 2 generations backK033217 Pheron Pta CatheterBiotronik, Inc. · 2003
- 1 generation backK072765 Passeo 18Biotronik, Inc. · 2007
- This deviceK082933 Passeo-35 Pta CatheterBiotronik, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK142379 Passeo-35 PTA CatheterBiotronik, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK222065 Passeo-35 Xeo Peripheral Dilatation CatheterBiotronik, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK152240 Passeo-14 Peripheral Dilatation CatheterBiotronik, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK250706 Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral…Biotronik, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK130161 Passeo-35Biotronik, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K142379Passeo-35 PTA CatheterBiotronik, Inc. · 2014 · cites it directly3descendants
- K222065Passeo-35 Xeo Peripheral Dilatation CatheterBiotronik, Inc. · 2023 · 2 generations on1descendant
- K152240Passeo-14 Peripheral Dilatation CatheterBiotronik, Inc. · 2015 · 2 generations on1descendant
- K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…Biotronik, Inc. · 2025 · 3 generations on0descendants
- K130161Passeo-35Biotronik, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000101 | RX Viatrac 14 Peripheral Dilatation Catheter | Guidant Corp. | 2000 | — |
| −3 | K020854 | Modification to Fox Pta Catheter | Jomed AG | 2002 | — |
| −2 | K033217 | Pheron Pta Catheter | Biotronik, Inc. | 2003 | — |
| −1 | K072765 | Passeo 18 | Biotronik, Inc. | 2007 | — |
| 0 (this device) | K082933 | Passeo-35 Pta Catheter | Biotronik, Inc. | 2008 | — |
| +1 | K142379 | Passeo-35 PTA Catheter | Biotronik, Inc. | 2014 | — |
| +2 | K222065 | Passeo-35 Xeo Peripheral Dilatation Catheter | Biotronik, Inc. | 2023 | — |
| +2 | K152240 | Passeo-14 Peripheral Dilatation Catheter | Biotronik, Inc. | 2015 | — |
| +3 | K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation… | Biotronik, Inc. | 2025 | — |
| +1 | K130161 | Passeo-35 | Biotronik, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K033217 | Pheron Pta CatheterSummary page 1…proposes the following PTA catheters cleared through 510(k) notifications as the predicate devices for the Passeo-35 PTA Catheter: * BIOTRONIK's Pheron PTA Catheter (K033217, cleared October 31, 2003 and K052757, cleared October 28, 2005) * BIOTRONIK's Passeo-18 PTA Catheter (K072765, clear… | 2003 |
| * | K052757 | Pheron Peripheral Percutaneous Transluminal Angioplasty (Pta) CatheterSummary page 1…leared through 510(k) notifications as the predicate devices for the Passeo-35 PTA Catheter: * BIOTRONIK's Pheron PTA Catheter (K033217, cleared October 31, 2003 and K052757, cleared October 28, 2005) * BIOTRONIK's Passeo-18 PTA Catheter (K072765, cleared December 12, 2007) Indication for U… | 2005 |
| * | K072765 | Passeo 18Summary page 1…theter: * BIOTRONIK's Pheron PTA Catheter (K033217, cleared October 31, 2003 and K052757, cleared October 28, 2005) * BIOTRONIK's Passeo-18 PTA Catheter (K072765, cleared December 12, 2007) Indication for Use: The Passeo-35 peripheral dilatation catheter is indicated to dilate stenosis in t… | 2007 |
What descends from it? (5)
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 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K142379 (Biotronik, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K033217.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Passeo-35 peripheral dilatation catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082933 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082933: Passeo-35 Pta Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082933
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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