510(k) · Cleared
ClearedAxium Detachable Coil; Axium Prime Detachable Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular · HCG Device, Neurovascular Embolization
Cleared on Nov 7, 2023 as substantially equivalent to K203432 (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, 2021) after a 28-day review. Its family tree reaches back 16 generations to 1995.
- Decided
- Nov 7, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K951256 (1995). 64 ancestors in all, the oldest K860840 (1986). No later device cites it as a predicate yet.
- Root · 16 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 12 generations between
- 3 generations backK151447 Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015
- 2 generations backK162704 Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2017
- 1 generation backK203432 Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2021 · Recalled
- This deviceK233420 Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 2023
Show all 16 generations
- Root · 16 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 15 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 14 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 13 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 12 generations backK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
- 11 generations backK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
- 10 generations backK033813 Micrus Modified Microcoil System, CerecyteMicrus Corp. · 2004
- 9 generations backK053160 Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & CheMicrus Endovascular Corporation · 2005
- 8 generations backK062036 Micrus Microcoil System Presidio-18, Model PC4Micrus Endovascular Corporation · 2006 · Recalled
- 7 generations backK070707 Micrus Microcoil SystemMicrus Endovascular Corporation · 2007
- 6 generations backK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
- 5 generations backK081465 Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · Recalled
- 4 generations backK133310 Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014
- 3 generations backK151447 Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015
- 2 generations backK162704 Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2017
- 1 generation backK203432 Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2021 · Recalled
- This deviceK233420 Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −15 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −14 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −13 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −12 | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… | Boston Scientific, Target | 2000 | — |
| −11 | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01 | Micrus Corp. | 2002 | — |
| −10 | K033813 | Micrus Modified Microcoil System, Cerecyte | Micrus Corp. | 2004 | — |
| −9 | K053160 | Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & Che | Micrus Endovascular Corporation | 2005 | — |
| −8 | K062036 | Micrus Microcoil System Presidio-18, Model PC4 | Micrus Endovascular Corporation | 2006 | 1 |
| −7 | K070707 | Micrus Microcoil System | Micrus Endovascular Corporation | 2007 | — |
| −6 | K073442 | Micrus Microcoil Systems | Micrus Endovascular Corporation | 2008 | — |
| −5 | K081465 | Axium Detachable Coil System | Micro Therapeutics, Inc. | 2008 | 2 |
| −4 | K133310 | Axium Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014 | — |
| −3 | K151447 | Axium Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015 | — |
| −2 | K162704 | Axium Prime Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017 | — |
| −1 | K203432 | Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021 | 1 |
| 0 (this device) | K233420 | Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2007 | 3 | 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 HCG? 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 HCG device
- #1 K252700 Optima Coil System (Optima Packing Coil System)score 20.6 · 26 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K203432 | Axium Detachable Coil; Axium Prime Detachable CoilSummary page 4…Regulation Name: Neurovascular Embolization Device, Vascular Embolization Device Device Classification Class II Predicate Device: K203432 Axium™ Detachable Coil Axium™ Prime Detachable Coil Device Desc… | 2021 |
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 28 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 10 of the 64 ancestors have a recall of any class.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HCG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HCG
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HCG
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HCG
537in 2025
MAUDE reports naming product code HCG, 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 | 8 | 50 | 1 | 326 |
| 2008 | 9 | 71 | 3 | 730 |
| 2009 | 7 | 48 | 0 | 821 |
| 2010 | 8 | 72 | 2 | 851 |
| 2011 | 9 | 78 | 1 | 894 |
| 2012 | 7 | 30 | 0 | 1,146 |
| 2013 | 7 | 67 | 2 | 1,103 |
| 2014 | 5 | 66 | 4 | 1,729 |
| 2015 | 5 | 60 | 0 | 1,598 |
| 2016 | 7 | 37 | 0 | 1,991 |
| 2017 | 5 | 97 | 0 | 2,494 |
| 2018 | 4 | 173 | 0 | 2,058 |
| 2019 | 1 | — | 0 | 1,763 |
| 2020 | 2 | — | 0 | 1,754 |
| 2021 | 5 | 103 | 0 | 2,268 |
| 2022 | 3 | 114 | 2 | 663 |
| 2023 | 2 | — | 0 | 568 |
| 2024 | 4 | 49 | 1 | 552 |
| 2025 | 3 | 107 | 1 (1) | 537 |
| 2026 | 4 | 30 | 1 | — |
What is it indicated for?
Axium™ Detachable Coil: Axium™ Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. Axium™ Prime Detachable Coil: (Models: APB-X-Y-3D-ES, APB-X-Y-3D-SS, APB-X-Y-HX-ES, APB-X-Y-HX-SS) The Axium™ Prime Detachable Coils are intended for the endovascular…
Read the full statement (130 words)
Axium™ Detachable Coil:
Axium™ Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Axium™ Prime Detachable Coil:
(Models: APB-X-Y-3D-ES, APB-X-Y-3D-SS, APB-X-Y-HX-ES, APB-X-Y-HX-SS)
The Axium™ Prime Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The Axium™ Prime Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Axium™ Prime Detachable Coil:
(Models: FC-X-Y-3D)
The Axium™ Prime Detachable Coil is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Prime Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233420 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233420: Axium Detachable Coil; Axium Prime Detachable Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233420
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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