510(k) · Cleared
Cleared6F Proxis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St. Jude Medical, Inc. · DQY Catheter, Percutaneous
Cleared on Oct 2, 2008 as substantially equivalent to K063638 (St Jude Medical, 2007) and 1 other predicate after a 276-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Oct 2, 2008
- Review
- 276 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K010579 (2001). 23 ancestors in all, the oldest K913517 (1991). No later device cites it as a predicate yet.
- Root · 5 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 4 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 3 generations backK040869 Export CatheterMedtronic Vascular · 2004
- 2 generations backK050139 Modification to: Export CatheterMedtronic Vascular · 2005
- 1 generation backK052523 Proxis SystemVelocimed, Inc. · 2006
- This deviceK073700 6F Proxis SystemSt. Jude Medical, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −4 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −3 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| −2 | K050139 | Modification to: Export Catheter | Medtronic Vascular | 2005 | — |
| −1 | K052523 | Proxis System | Velocimed, Inc. | 2006 | — |
| 0 (this device) | K073700 | 6F Proxis System | St. Jude Medical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K063638 | Modification to Proxis System, Model Eps 101Summary page 3…stem passed all verification specification criteria for dimensional, strength. functional, packaging, sterilization, biocompatibility, and shelf life tests as cleared in K063638. Previously reviewed test results (K063638 and K052523) confirm the device performs as intended without raising additional questi… | 2007 |
| * | K052523 | Proxis SystemSummary page 3…dimensional, strength. functional, packaging, sterilization, biocompatibility, and shelf life tests as cleared in K063638. Previously reviewed test results (K063638 and K052523) confirm the device performs as intended without raising additional questions of safety and efficacy. Given the scope of the… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 1.3 years on median.
- 3 of the 23 ancestors have a recall of any class.
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 6F Proxis System controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporary vessel occlusion to hold a column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solutions. The 6F Proxis System is also indicated for use as an aid in the removal of fresh, soft emboli and thrombi in the…
Read the full statement (127 words)
The 6F Proxis System controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporary vessel occlusion to hold a column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solutions.
The 6F Proxis System is also indicated for use as an aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature.
The safety and efficacy of this device as an embolic protection system has not been established. The 6F Proxis System is not indicated for use for embolic protection. The device is not intended to be used as a thrombectomy system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073700 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073700: 6F Proxis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073700
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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