510(k) · Cleared
ClearedGuglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum Coils, Acce
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Target Therapeutics · DQX Wire, Guide, Catheter
Cleared on Jul 14, 1997 as substantially equivalent to K962503 (Target Therapeutics, 1996) and 17 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1995. 1 of the 172 devices in its family, counting itself, has a Class I recall. 150 later devices descend from it.
- Decided
- Jul 14, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 19
Its longest line of descent runs back 3 generations to K951256 (1995). 21 ancestors in all, the oldest K860840 (1986). 150 later devices descend from it, 5 citing it directly. 1 of the 172 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 2 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 1 generation backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- This deviceK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- Descendant · cites it directly · 138 of its ownK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- Descendant · cites it directly · 105 of its ownK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
- Descendant · 2 generations on · 103 of its ownK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
- Descendant · cites it directly · 98 of its ownK993417 GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18…Boston Scientific, Target · 2000
- Descendant · 2 generations on · 96 of its ownK012145 Microplex Coil SystemMicroVention, Inc. · 2001
Showing 5 of 150 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…6 generations on · 2022
Most influential descendants
Showing 5 of 150 · See all- K991139Guglielmi Detachable (GDC)Boston Scientific, Target · 1999 · cites it directly138descendants
- K993415GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant…Boston Scientific, Target · 2000 · cites it directly105descendants
- K022420Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002 · 2 generations on103descendants
- K993417GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil…Boston Scientific, Target · 2000 · cites it directly98descendants
- K012145Microplex Coil SystemMicroVention, Inc. · 2001 · 2 generations on96descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −2 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −1 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| 0 (this device) | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| +1 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| +1 | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… | Boston Scientific, Target | 2000 | — |
| +2 | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01 | Micrus Corp. | 2002 | — |
| +1 | K993417 | GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi… | Boston Scientific, Target | 2000 | — |
| +2 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 8 | 0 |
| 2009 | 10 | 0 |
| 2010 | 7 | 0 |
| 2011 | 9 | 0 |
| 2012 | 11 | 0 |
| 2013 | 11 | 0 |
| 2014 | 7 | 0 |
| 2015 | 8 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 6 | 0 |
| 2022 | 7 | 1 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 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 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? (19)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962503 | Guglielmi Detachable CoilSummary page 1…DEVICE DESCRIPTIONS: Please refer to Table 1 (Page 10) INDICATIONS FOR USE: Please refer to Table 2 (Pages 13 and 14) PREDICATE DEVICES: * Guglielmi Detachable Coil - K962503 ¢ TRACKER Infusion Catheters - K925813 * GUIDEWIRES * STEALTH Dilatation Catheters - K915895 - Dasher - K950069, K915115 - Taper… | 1996 |
| * | K925813 | Diagnostic Intravascular CatheterSummary page 1…Table 1 (Page 10) INDICATIONS FOR USE: Please refer to Table 2 (Pages 13 and 14) PREDICATE DEVICES: * Guglielmi Detachable Coil - K962503 ¢ TRACKER Infusion Catheters - K925813 * GUIDEWIRES * STEALTH Dilatation Catheters - K915895 - Dasher - K950069, K915115 - Taper - K924987, K880762 ¢ ACCESSORIES - Seek… | 1994 |
| * | K950069 | Dasher-14Summary page 1…and 14) PREDICATE DEVICES: * Guglielmi Detachable Coil - K962503 ¢ TRACKER Infusion Catheters - K925813 * GUIDEWIRES * STEALTH Dilatation Catheters - K915895 - Dasher - K950069, K915115 - Taper - K924987, K880762 ¢ ACCESSORIES - Seeker - K912293, K922912 - Rotating Hemostatic Valve - K873971 - Stubbie - K… | 1995 |
| * | K915115 | Guider DasherSummary page 1…PREDICATE DEVICES: * Guglielmi Detachable Coil - K962503 ¢ TRACKER Infusion Catheters - K925813 * GUIDEWIRES * STEALTH Dilatation Catheters - K915895 - Dasher - K950069, K915115 - Taper - K924987, K880762 ¢ ACCESSORIES - Seeker - K912293, K922912 - Rotating Hemostatic Valve - K873971 - Stubbie - K912293 -… | 1992 |
| * | K924987 | Taper GuidewiresSummary page 1…* Guglielmi Detachable Coil - K962503 ¢ TRACKER Infusion Catheters - K925813 * GUIDEWIRES * STEALTH Dilatation Catheters - K915895 - Dasher - K950069, K915115 - Taper - K924987, K880762 ¢ ACCESSORIES - Seeker - K912293, K922912 - Rotating Hemostatic Valve - K873971 - Stubbie - K912293 - Guidewire Introduc… | 1992 |
| * | K880762 | Taper Flex-Tip Steerable GuidewireSummary page 1…lmi Detachable Coil - K962503 ¢ TRACKER Infusion Catheters - K925813 * GUIDEWIRES * STEALTH Dilatation Catheters - K915895 - Dasher - K950069, K915115 - Taper - K924987, K880762 ¢ ACCESSORIES - Seeker - K912293, K922912 - Rotating Hemostatic Valve - K873971 - Stubbie - K912293 - Guidewire Introducer - K873… | 1988 |
| * | K912293 | Remove Labeling Restrict From Guide WiresSummary page 1…RACKER Infusion Catheters - K925813 * GUIDEWIRES * STEALTH Dilatation Catheters - K915895 - Dasher - K950069, K915115 - Taper - K924987, K880762 ¢ ACCESSORIES - Seeker - K912293, K922912 - Rotating Hemostatic Valve - K873971 - Stubbie - K912293 - Guidewire Introducer - K873972 - Guidewire Torquer - K860840… | 1991 |
| * | K922912 | Seeker Lite - 10Summary page 1…fusion Catheters - K925813 * GUIDEWIRES * STEALTH Dilatation Catheters - K915895 - Dasher - K950069, K915115 - Taper - K924987, K880762 ¢ ACCESSORIES - Seeker - K912293, K922912 - Rotating Hemostatic Valve - K873971 - Stubbie - K912293 - Guidewire Introducer - K873972 - Guidewire Torquer - K860840 * OCCLUS… | 1992 |
| * | K915895 | Stealth Dilation Catheter System (Modified)Summary page 1…o Table 2 (Pages 13 and 14) PREDICATE DEVICES: * Guglielmi Detachable Coil - K962503 ¢ TRACKER Infusion Catheters - K925813 * GUIDEWIRES * STEALTH Dilatation Catheters - K915895 - Dasher - K950069, K915115 - Taper - K924987, K880762 ¢ ACCESSORIES - Seeker - K912293, K922912 - Rotating Hemostatic Valve - K8… | 1992 |
| * | K955293 | Fibered Platinum Coil, .035 TypeSummary page 1…Stubbie - K912293 - Guidewire Introducer - K873972 - Guidewire Torquer - K860840 * OCCLUSION COILS - Coil Pusher - K911779, K891688 - Fibered Platinum Coil, .035" Type - K955293 - Shaping Mandrel - K951159 - Berenstein Liquid Coil - K964112 - Valve Wire - K915895, K90428 - Occlusion Coils - K914786 Expirat… | 1996 |
| * | K964112 | Berenstein CoilSummary page 1…Torquer - K860840 * OCCLUSION COILS - Coil Pusher - K911779, K891688 - Fibered Platinum Coil, .035" Type - K955293 - Shaping Mandrel - K951159 - Berenstein Liquid Coil - K964112 - Valve Wire - K915895, K90428 - Occlusion Coils - K914786 Expiration Date / Shelf Life Page 16 . 510(K) - Target Therapeutics :… | 1997 |
| * | K914786 | Target Therapeutics CoilsSummary page 1…, K891688 - Fibered Platinum Coil, .035" Type - K955293 - Shaping Mandrel - K951159 - Berenstein Liquid Coil - K964112 - Valve Wire - K915895, K90428 - Occlusion Coils - K914786 Expiration Date / Shelf Life Page 16 . 510(K) - Target Therapeutics : ‘ \A% TESTING in SUPPORT of SUBSTANTIAL EQ… | 1992 |
| * | K873971 | Rotating Hemostatic ValveSummary page 1…S * STEALTH Dilatation Catheters - K915895 - Dasher - K950069, K915115 - Taper - K924987, K880762 ¢ ACCESSORIES - Seeker - K912293, K922912 - Rotating Hemostatic Valve - K873971 - Stubbie - K912293 - Guidewire Introducer - K873972 - Guidewire Torquer - K860840 * OCCLUSION COILS - Coil Pusher - K911779, K89… | 1988 |
| * | K873972 | Guide Wire IntroducerSummary page 1…K950069, K915115 - Taper - K924987, K880762 ¢ ACCESSORIES - Seeker - K912293, K922912 - Rotating Hemostatic Valve - K873971 - Stubbie - K912293 - Guidewire Introducer - K873972 - Guidewire Torquer - K860840 * OCCLUSION COILS - Coil Pusher - K911779, K891688 - Fibered Platinum Coil, .035" Type - K955293 -… | 1988 |
| * | K860840 | Guided Wire TorquerSummary page 1…24987, K880762 ¢ ACCESSORIES - Seeker - K912293, K922912 - Rotating Hemostatic Valve - K873971 - Stubbie - K912293 - Guidewire Introducer - K873972 - Guidewire Torquer - K860840 * OCCLUSION COILS - Coil Pusher - K911779, K891688 - Fibered Platinum Coil, .035" Type - K955293 - Shaping Mandrel - K951159 - Be… | 1986 |
| * | K911779 | Helix Shaped Coils with Dacron Fibers, ModifiedSummary page 1…12293, K922912 - Rotating Hemostatic Valve - K873971 - Stubbie - K912293 - Guidewire Introducer - K873972 - Guidewire Torquer - K860840 * OCCLUSION COILS - Coil Pusher - K911779, K891688 - Fibered Platinum Coil, .035" Type - K955293 - Shaping Mandrel - K951159 - Berenstein Liquid Coil - K964112 - Valve Wir… | 1991 |
| * | K891688 | Coil and Coil Delivery SystemSummary page 1…22912 - Rotating Hemostatic Valve - K873971 - Stubbie - K912293 - Guidewire Introducer - K873972 - Guidewire Torquer - K860840 * OCCLUSION COILS - Coil Pusher - K911779, K891688 - Fibered Platinum Coil, .035" Type - K955293 - Shaping Mandrel - K951159 - Berenstein Liquid Coil - K964112 - Valve Wire - K9158… | 1989 |
| * | K951159 | FasguideSummary page 1…e Introducer - K873972 - Guidewire Torquer - K860840 * OCCLUSION COILS - Coil Pusher - K911779, K891688 - Fibered Platinum Coil, .035" Type - K955293 - Shaping Mandrel - K951159 - Berenstein Liquid Coil - K964112 - Valve Wire - K915895, K90428 - Occlusion Coils - K914786 Expiration Date / Shelf Life Page 1… | 1995 |
| Kept off the family tree | K090428 | FDA’s K090428 is Ats Simulus Adjustable Flexible Annuloplasty, Model 735 AC Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
What descends from it? (150)
See all 1505 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991139 | Guglielmi Detachable (GDC) | 1999 | 138 |
| K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant… | 2000 | 105 |
| K993417 | GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil… | 2000 | 98 |
| K993418 | Fibered GDC-18 Vortx Shape Guglielmi Detachable Coil | 2000 | 69 |
| K014041 | Trufill DCS Detachable Coil and Frufill DCS Syringe, Also Known as the Trufill DCS… | 2002 | 0 |
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.
- K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft…Medos International SARL · 2022 · 6 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 8 months on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K991139 (Boston Scientific, Target, 1999) has gone furthest, with 138 descendants of its own.
- 9 other devices also cite its predicate K962503.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
For embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team-to-be a) very high risk for management by traditionat-operative techniques, or byinoperable; and-for embolizing other vascular malformation such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. The GDC is also intended for…
Read the full statement (357 words)
For embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team-to-be a) very high risk for management by traditionat-operative techniques, or byinoperable; and-for embolizing other vascular malformation such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. The GDC is also intended for arterial and venous enbolizations in the peripheral vasculature.
For arterial and venous embolizations in the peripheral vasculature
For the embolization of vascular malformations of the peripheral, coronary an neuro vasculature. Coils are intended to obstruct or reduce blood flow in the peripheral and neurovasculature. They are intended for use in the interventional rediologic management of arteriovenous mafformations and arteriovenous fistulas when devascularization prior to definitive surgical resection is desirable.
Target Therapeutics Steerable Guidewires are designed to assist in the delivery of Tracker Infusion Catheters to selected vascular sites.
Tracker Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature.
The Stealth Dilatation Catheter System is intended for the dilatation of peripheral vasculature (PTA). This device is no intended for use in the coronary arteries.
The coil pusher is a guidewire-like device consisting of a stainless stee! wire with a radiopaque gold marker at its tip. The coil pusher is intended to be used by the physician in deploying the coil to the site.
The guidewire introducer consists of a cannula and luer used to introduce guidewires into catheter hubs or hemostatic valves.
The guidewire torquer was developed to enhance contro! of torqueable guidewires during intravascular placement.
To maintain a fluid tight seal at the point of entry when a guiding catheter or sheath is used to support the placement of a therapeutic or diagnostic catheter.
The Shaping Mandrel is a stainless steel accessory device used by physicians to form or shape a catheter tip to suit the requirements of a particular case.
The Valve Wire is used in conjunction with Stealth balloon dilatation catheters to seal the distal end of the balloon section enabling it to be inflated.
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/K971395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971395: Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum Coils, Acce.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971395
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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