510(k) · Cleared
ClearedAzur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MicroVention, Inc. · HCG Device, Neurovascular Embolization
Cleared on Mar 12, 2009 as substantially equivalent to K050954 (MicroVention, Inc., 2005) after a 48-day review. Its family tree reaches back 11 generations to 1995. 18 later devices descend from it.
- Decided
- Mar 12, 2009
- Review
- 48 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K951256 (1995). 42 ancestors in all, the oldest K860840 (1986). 18 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 7 generations between
- 3 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 2 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- 1 generation backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- This deviceK090168 Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415MicroVention, Inc. · 2009
- Descendant · cites it directly · 12 of its ownK093002 Azur Peripheral Hydrocoil Endovascular Embolization…MicroVention, Inc. · 2009
- Descendant · 2 generations on · 10 of its ownK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- Descendant · 3 generations on · 6 of its ownK133282 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- Descendant · 3 generations on · 5 of its ownK141313 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014
- Descendant · 3 generations on · 4 of its ownK150108 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2015
Show all 11 generations
- Root · 11 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 10 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 9 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 8 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 7 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 6 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 5 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- 4 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 3 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 2 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- 1 generation backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- This deviceK090168 Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415MicroVention, Inc. · 2009
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K093002Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models…MicroVention, Inc. · 2009 · cites it directly12descendants
- K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013 · 2 generations on10descendants
- K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013 · 3 generations on6descendants
- K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014 · 3 generations on5descendants
- K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −10 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −9 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −8 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −7 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −6 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| −5 | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| −4 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −3 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −2 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| −1 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
| 0 (this device) | K090168 | Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415 | MicroVention, Inc. | 2009 | — |
| +1 | K093002 | Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35… | MicroVention, Inc. | 2009 | — |
| +2 | K123803 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| +3 | K133282 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| +3 | K141313 | Reverse Medical Micro Vascular Plug System | Reverse Medical Corporation | 2014 | — |
| +3 | K150108 | Reverse Medical Micro Vascular Plug System | Reverse Medical Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)Summary page 1…MicroVention, Inc 75 Columbia Aliso. Viejo, California U.S.A. Contact: Florin Truuvert Predicate Device: K050954 MicroVention Inc. HydroCoil Embolic June 28, 2005 System (LHES) Device Description T… | 2005 |
What descends from it? (18)
See all 182 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 14 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 8 of the 42 ancestors have a recall of any class.
- Of its descendants, K093002 (MicroVention, Inc., 2009) has gone furthest, with 12 descendants of its own.
- 8 other devices also cite its predicate K050954.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Azur Detachable Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous fistula.
The coils are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct bloodflow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090168: Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090168
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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