510(k) · Cleared
Recalled · Class I · 2016Findrwirz Guide Wire System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sentreheart, Inc. · DQX Wire, Guide, Catheter
Cleared on Aug 11, 2008 as substantially equivalent to K914138 (Lake Region Mfg., Inc., 1991) and 2 other predicates after a 182-day review. Its family tree reaches back 4 generations to 1994. 2 of the 23 devices in its family, counting itself, have a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Aug 11, 2008
- Review
- 182 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 1 (1 Class I)
- Predicates
- 3
Its longest line of descent runs back 4 generations to K941895 (1994). 22 ancestors in all, the oldest K901502 (1990). No later device cites it as a predicate yet. 2 of the 23 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK941895 Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic CoatingScimed Life Systems, Inc. · 1994
- 3 generations backK970244 Scimed Choice Family of Ptca Guide WiresScimed Life Systems, Inc. · 1997
- 2 generations backK021363 Endovascular Guide WireStereotaxis, Inc. · 2002 · Recalled
- 1 generation backK042854 Stereotaxis Endovascular Guide WireStereotaxis, Inc. · 2005
- This deviceK080364 Findrwirz Guide Wire SystemSentreheart, Inc. · 2008
Class I recalls in this family
- K970466 Radius Ptca Guidewire3 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941895 | Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic Coating | Scimed Life Systems, Inc. | 1994 | — |
| −3 | K970244 | Scimed Choice Family of Ptca Guide Wires | Scimed Life Systems, Inc. | 1997 | — |
| −2 | K021363 | Endovascular Guide Wire | Stereotaxis, Inc. | 2002 | 6 |
| −1 | K042854 | Stereotaxis Endovascular Guide Wire | Stereotaxis, Inc. | 2005 | — |
| 0 (this device) | K080364 | Findrwirz Guide Wire System | Sentreheart, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 6 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 1 |
| 1998 | 1 | 0 |
| 2002 | 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.
2 devices in this family have 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 DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 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 |
|---|---|---|---|
| * | K914138 | OntracSummary page 2…ntional devices and Inferior Vena Cava (IVC) filters. The FindrWIRZ system is also contraindicated for use in MRI procedures. Predicate Devices: OnTrac, Lake Region (K914138) Cronus Wire, Stereotaxis (K042854) Radius Snare Device, Radius Medical Technologies (K071457) Safety and Performance: Perform… | 1991 |
| * | K042854 | Stereotaxis Endovascular Guide WireSummary page 2…va (IVC) filters. The FindrWIRZ system is also contraindicated for use in MRI procedures. Predicate Devices: OnTrac, Lake Region (K914138) Cronus Wire, Stereotaxis (K042854) Radius Snare Device, Radius Medical Technologies (K071457) Safety and Performance: Performance Functional testing was conducte… | 2005 |
| * | K071457 | Modification to Radius SnareSummary page 2…ted for use in MRI procedures. Predicate Devices: OnTrac, Lake Region (K914138) Cronus Wire, Stereotaxis (K042854) Radius Snare Device, Radius Medical Technologies (K071457) Safety and Performance: Performance Functional testing was conducted to support the claim of substantial equivalence and to dem… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 29, 2016 | Class I | Z-0328-2017 | Under Investigation by firm | A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .025 guidewires removed from their packaging hoops. |
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.
- K970466Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997 · 3 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 5 of the 22 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K914138.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, 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 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
The FindrWIRZ System is intended for use in the cardiovascular system for introduction and positioning of over-the-wire catheters and therapeutic devices during interventional procedures. A FindrWIRZ may also be used to manipulate and or reposition another FindrWIRZ.
The FindrWIRZ System is not intended for use in the coronary or cerebral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080364: Findrwirz Guide Wire System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080364
Report an extraction error
Are you the manufacturer?
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