510(k) · Cleared
ClearedAxium Prime Detachable Coil System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · HCG Device, Neurovascular Embolization
Cleared on Jan 3, 2017 as substantially equivalent to K151447 (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, 2015) and 3 other predicates after a 97-day review. Its family tree reaches back 14 generations to 1995. 4 later devices descend from it.
- Decided
- Jan 3, 2017
- Review
- 97 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K951256 (1995). 62 ancestors in all, the oldest K860840 (1986). 4 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 10 generations between
- 3 generations backK081465 Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · Recalled
- 2 generations backK133310 Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014
- 1 generation backK151447 Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015
- This deviceK162704 Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2017
- Descendant · cites it directly · 1 of its ownK203432 Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK233420 Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 2023
- Descendant · cites it directly · 0 of its ownK180653 Spartan eCoil SystemSpartan Micro, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK173711 Wallaby Avenir Coil SystemWallaby Medical, Inc. · 2018
Show all 14 generations
- Root · 14 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 13 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 12 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 11 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 10 generations backK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
- 9 generations backK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
- 8 generations backK033813 Micrus Modified Microcoil System, CerecyteMicrus Corp. · 2004
- 7 generations backK053160 Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & CheMicrus Endovascular Corporation · 2005
- 6 generations backK062036 Micrus Microcoil System Presidio-18, Model PC4Micrus Endovascular Corporation · 2006 · Recalled
- 5 generations backK070707 Micrus Microcoil SystemMicrus Endovascular Corporation · 2007
- 4 generations backK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
- 3 generations backK081465 Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · Recalled
- 2 generations backK133310 Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014
- 1 generation backK151447 Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015
- This deviceK162704 Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2017
Most influential descendants
Showing 4 of 4 · See all- K203432Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2021 · cites it directly1descendant
- K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 2023 · 2 generations on0descendants
- K180653Spartan eCoil SystemSpartan Micro, Inc. · 2018 · cites it directly0descendants
- K173711Wallaby Avenir Coil SystemWallaby Medical, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −13 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −12 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −11 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −10 | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… | Boston Scientific, Target | 2000 | — |
| −9 | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01 | Micrus Corp. | 2002 | — |
| −8 | K033813 | Micrus Modified Microcoil System, Cerecyte | Micrus Corp. | 2004 | — |
| −7 | K053160 | Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & Che | Micrus Endovascular Corporation | 2005 | — |
| −6 | K062036 | Micrus Microcoil System Presidio-18, Model PC4 | Micrus Endovascular Corporation | 2006 | 1 |
| −5 | K070707 | Micrus Microcoil System | Micrus Endovascular Corporation | 2007 | — |
| −4 | K073442 | Micrus Microcoil Systems | Micrus Endovascular Corporation | 2008 | — |
| −3 | K081465 | Axium Detachable Coil System | Micro Therapeutics, Inc. | 2008 | 2 |
| −2 | K133310 | Axium Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014 | — |
| −1 | K151447 | Axium Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015 | — |
| 0 (this device) | 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 |
| +2 | K233420 | Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2023 | — |
| +1 | K180653 | Spartan eCoil System | Spartan Micro, Inc. | 2018 | — |
| +1 | K173711 | Wallaby Avenir Coil System | Wallaby Medical, Inc. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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.
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? (4)
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 |
|---|---|---|---|
| * | K151447 | Axium Detachable Coil SystemSummary page 4…e Device: Classification of 21 CFR 882.5950 – Class II Device: Product Code HCG and KRD Predicate Device: Axium™ Detachable Coil System: K151447, cleared July 28, 2015 K133310, cleared January 10, 2014 K081465, cleared August 19,… | 2015 |
| * | K133310 | Axium Detachable Coil SystemSummary page 4…II Device: Product Code HCG and KRD Predicate Device: Axium™ Detachable Coil System: K151447, cleared July 28, 2015 K133310, cleared January 10, 2014 K081465, cleared August 19, 2008 K060747, cleared April 24,… | 2014 |
| * | K081465 | Axium Detachable Coil SystemSummary page 4…vice: Axium™ Detachable Coil System: K151447, cleared July 28, 2015 K133310, cleared January 10, 2014 K081465, cleared August 19, 2008 K060747, cleared April 24, 2007 Performance Data: The following bench tests wer… | 2008 |
| * | K060747 | FX Detachable Coil SystemSummary page 4… K151447, cleared July 28, 2015 K133310, cleared January 10, 2014 K081465, cleared August 19, 2008 K060747, cleared April 24, 2007 Performance Data: The following bench tests were performed to support the addition of… | 2007 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 62 ancestors have a recall of any class.
- Of its descendants, K203432 (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K151447.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The Axium Prime Detachable Coil System is indicated 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 indicated for arterial and venous embolizations in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162704: Axium Prime Detachable Coil System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162704
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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