510(k) · Cleared
Recalled · Class I · 2013GT1 Floppy, GT1 HI-Per Flex, GT1 Light Support
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arterial Vascular Engineering, Inc. · DQT Occluder, Catheter Tip
Cleared on Mar 11, 1999 after a 126-day review. The FDA summary names its predicate without a number. 2 of the 6 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Mar 11, 1999
- Review
- 126 days
- Class
- Class II
- Product code
- DQT
- Recalls
- 2 (2 Class I)
- Predicates
- 0
5 later devices descend from it, 4 citing it directly. 2 of the 6 devices in this family, counting this one, have a Class I recall.
- This deviceK983927 GT1 Floppy, GT1 HI-Per Flex, GT1 Light SupportArterial Vascular Engineering, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK063210 Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478…Medtronic Inc. Cardiac Rhythm Management · 2007 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK143316 Attain Hybrid Guide WireMedtronic, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK140695 Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia…Medtronic, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK101729 Neowire Pta/Ptca GuidewireNeometrics, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK992237 Medtronic GT2 Fusion Guide WiresMedtronic Vascular · 1999
Class I recalls in this family
- K063210 Attain Hybrid Guide Wires, Model GWR419378…cites it directly · 2007
Most influential descendants
Showing 5 of 5 · See all- K063210Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488Medtronic Inc. Cardiac Rhythm Management · 2007 · cites it directly1descendant
- K143316Attain Hybrid Guide WireMedtronic, Inc. · 2015 · 2 generations on0descendants
- K140695Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire, Intuition…Medtronic, Inc. · 2014 · cites it directly0descendants
- K101729Neowire Pta/Ptca GuidewireNeometrics, Inc. · 2010 · cites it directly0descendants
- K992237Medtronic GT2 Fusion Guide WiresMedtronic Vascular · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983927 | GT1 Floppy, GT1 HI-Per Flex, GT1 Light Support | Arterial Vascular Engineering, Inc. | 1999 | — |
| +1 | K063210 | Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488 | Medtronic Inc. Cardiac Rhythm Management | 2007 | Class I |
| +2 | K143316 | Attain Hybrid Guide Wire | Medtronic, Inc. | 2015 | — |
| +1 | K140695 | Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire… | Medtronic, Inc. | 2014 | — |
| +1 | K101729 | Neowire Pta/Ptca Guidewire | Neometrics, Inc. | 2010 | — |
| +1 | K992237 | Medtronic GT2 Fusion Guide Wires | Medtronic Vascular | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2007 | 1 | 1 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Commander Floppy Named without a submission number | |
| * | — | Commander Hi-Per Flex Named without a submission number | |
| * | — | Commander Light Support Named without a submission number |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063210 | Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488 Class I | 2007 | 1 |
| K140695 | Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire, Intuition… | 2014 | 0 |
| K101729 | Neowire Pta/Ptca Guidewire | 2010 | 0 |
| K992237 | Medtronic GT2 Fusion Guide Wires | 1999 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 21, 2013 | Class I | Z-0268-2014 | Nonconforming Material/Component | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. |
| Oct 21, 2013 | Class I | Z-0262-2014 | Nonconforming Material/Component | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. |
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.
- K063210Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488Medtronic Inc. Cardiac Rhythm Management · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K063210 (Medtronic Inc. Cardiac Rhythm Management, 2007) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DQT devicesDQT Occluder, Catheter Tip: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQT
FDA has decided no DQT device since 2007.
Median 510(k) review, days · DQT
Too few DQT 510(k)s in any year since 2007 to give a median.
Recalls per year · DQT
2in 2013
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DQT
1in 2025
MAUDE reports naming product code DQT, 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 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 2 (2) | 3 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 21 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
AVE guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. AVE guide wires are not intended for use in the cerebral vasculature. AVE steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983927: GT1 Floppy, GT1 HI-Per Flex, GT1 Light Support.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983927
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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