510(k) · Cleared
ClearedProgigy Support Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radius Medical, LLC · DQY Catheter, Percutaneous
Cleared on Aug 22, 2013 as substantially equivalent to K082337 (Vascular Solutions, Inc., 2009) and 1 other predicate after a 160-day review. Its family tree reaches back 6 generations to 1994. 1 of the 18 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Aug 22, 2013
- Review
- 160 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K935425 (1994). 13 ancestors in all, the oldest P860019 (1986). 4 later devices descend from it, 1 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
- 5 generations backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
- 4 generations backK022138 Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002
- 3 generations backK033678 Spectranetics Quick Cross Catheters, Models 518-032, 518-033…Spectranetics Corp. · 2004
- 2 generations backK052258 Vascular Solutions Skyway Support CatheterVascular Solutions, Inc. · 2005
- 1 generation backK082337 Minnie Support CatheterVascular Solutions, Inc. · 2009
- This deviceK130714 Progigy Support CatheterRadius Medical, LLC · 2013
- Descendant · cites it directly · 3 of its ownK140910 Centercross CatheterRoxwood Medical, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK152456 CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK160681 CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016
- Descendant · 4 generations on · 0 of its ownK170403 CenterCross Ultra LV CatheterRoxwood Medical, Inc. · 2017
Class I recalls in this family
- K060327 Vascular Solutions Twin-Pass Dual Access…2 generations back · 2006
Most influential descendants
Showing 4 of 4 · See all- K140910Centercross CatheterRoxwood Medical, Inc. · 2014 · cites it directly3descendants
- K152456CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016 · 2 generations on2descendants
- K160681CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016 · 3 generations on1descendant
- K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc. · 2017 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935425 | Metronic Buchbinder Envoy Percutaneous Catheters | Medtronics Interventional Vascular | 1994 | — |
| −5 | K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018… | Spectranetics Corp. | 1999 | — |
| −4 | K022138 | Spectranetics 0.035 Support Catheter, Model 518-028 | Spectranetics Corp. | 2002 | — |
| −3 | K033678 | Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035… | Spectranetics Corp. | 2004 | — |
| −2 | K052258 | Vascular Solutions Skyway Support Catheter | Vascular Solutions, Inc. | 2005 | — |
| −1 | K082337 | Minnie Support Catheter | Vascular Solutions, Inc. | 2009 | — |
| 0 (this device) | K130714 | Progigy Support Catheter | Radius Medical, LLC | 2013 | — |
| +1 | K140910 | Centercross Catheter | Roxwood Medical, Inc. | 2014 | — |
| +2 | K152456 | CenterCross Ultra Catheter | Roxwood Medical, Inc. | 2016 | — |
| +3 | K160681 | CenterCross Ultra Catheter | Roxwood Medical, Inc. | 2016 | — |
| +4 | K170403 | CenterCross Ultra LV Catheter | Roxwood Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 1 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 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.
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? (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 |
|---|---|---|---|
| * | K082337 | Minnie Support CatheterSummary page 1…tion Name: Percutaneous catheter (21 CER 870.1250, Product Code DQY) 3. Predicate Devices MinnicTM Support Catheter (K082337) manufactured by Vascular Solutions, Inc. Maverick XL PTCA Catheter (P860019/183) manufactured by Boston Scientific.… | 2009 |
| * | P860019 | Scimed Ptca Dilatation CatheterSummary page 1…, Product Code DQY) 3. Predicate Devices MinnicTM Support Catheter (K082337) manufactured by Vascular Solutions, Inc. Maverick XL PTCA Catheter (P860019/183) manufactured by Boston Scientific. NC Quantum Apex OTW PTCA Dilatation Catheter (P860019/24 1) manufactured… | 1986 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140910 | Centercross Catheter | 2014 | 3 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · 2 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K140910 (Roxwood Medical, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K082337.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Prodigy Support Catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130714: Progigy Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130714
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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