510(k) · Cleared
Recalled · 2010FX Detachable Coil System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics, Inc. · HCG Device, Neurovascular Embolization
Cleared on Apr 24, 2007 as substantially equivalent to K041649 (Micro Therapeutics, Inc., 2004) and 3 other predicates after a 400-day review. Its family tree reaches back 5 generations to 1990. 23 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 24, 2007
- Review
- 400 days
- Class
- Class II
- Product code
- HCG
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 5 generations to K901337 (1990). 11 ancestors in all. 23 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK901337 Hilal Embolization Microcoil (TM)Cook, Inc. · 1990 · Recalled
- 4 generations backK033372 Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone…Micro Therapeutics, Inc. · 2004
- 3 generations backK041649 Sapphire NXT Detachable Coil SystemMicro Therapeutics, Inc. · 2004
- 2 generations backK050543 Nexus Detachable Coil SystemMicro Therapeutics, Inc. · 2005
- 1 generation backK051425 Nexus Detachable Coil System, Helix Super Soft CSRMicro Therapeutics, Inc. · 2005
- This deviceK060747 FX Detachable Coil SystemMicro Therapeutics, Inc. · 2007
- Descendant · cites it directly · 22 of its ownK081465 Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 10 of its ownK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- Descendant · 2 generations on · 6 of its ownK133310 Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014
- Descendant · 3 generations on · 6 of its ownK133282 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- Descendant · cites it directly · 5 of its ownK151447 Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K081465Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · cites it directly22descendants
- K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013 · 2 generations on10descendants
- K133310Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014 · 2 generations on6descendants
- K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013 · 3 generations on6descendants
- K151447Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2015 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901337 | Hilal Embolization Microcoil (TM) | Cook, Inc. | 1990 | 2 |
| −4 | K033372 | Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple Models | Micro Therapeutics, Inc. | 2004 | — |
| −3 | K041649 | Sapphire NXT Detachable Coil System | Micro Therapeutics, Inc. | 2004 | — |
| −2 | K050543 | Nexus Detachable Coil System | Micro Therapeutics, Inc. | 2005 | — |
| −1 | K051425 | Nexus Detachable Coil System, Helix Super Soft CSR | Micro Therapeutics, Inc. | 2005 | — |
| 0 (this device) | K060747 | FX Detachable Coil System | Micro Therapeutics, Inc. | 2007 | — |
| +1 | K081465 | Axium Detachable Coil System | Micro Therapeutics, Inc. | 2008 | 2 |
| +2 | K123803 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| +2 | K133310 | Axium Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014 | — |
| +3 | K133282 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| +1 | K151447 | Axium Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K041649 | Sapphire NXT Detachable Coil SystemSummary page 1…, California 92618 Contact: Florin Truuvert Predicate Device: Nu r Descriptionicate CiearanceIDte K041649 Sapphire NXT Detachable FX Detachable Coil System July 16, 2004 Coil System K050543… | 2004 |
| * | K050543 | Nexus Detachable Coil SystemSummary page 1…Descriptionicate CiearanceIDte K041649 Sapphire NXT Detachable FX Detachable Coil System July 16, 2004 Coil System K050543 Nexus Detachable Coil FX Detachable Coil System April 27, 2005 K051425 System… | 2005 |
| * | K051425 | Nexus Detachable Coil System, Helix Super Soft CSRSummary page 1…etachable Coil System July 16, 2004 Coil System K050543 Nexus Detachable Coil FX Detachable Coil System April 27, 2005 K051425 System June 22, 2005 K051560… | 2005 |
| * | K051560 | Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRSummary page 1…Nexus Detachable Coil FX Detachable Coil System April 27, 2005 K051425 System June 22, 2005 K051560 June 28, 2005 Device Description The FX Detachable Coil… | 2005 |
What descends from it? (23)
See all 234 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 1, 2010 | Not classified | Z-0873-2012 | Employee error | ev3 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as the lots were swapped in production. |
| Nov 12, 2008 | Not classified | Z-0841-2012 | Process control | ev3 Neurovascular has identified an incorrect expiration date on the label of one lot of ev3 Axium coils Catalog QC-2-2-3D. This lot 5871057 shows an expiration date of 0211-04. The expiration date should read 2011-04. There are no… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K081465 (Micro Therapeutics, Inc., 2008) has gone furthest, with 22 descendants of its own.
- 1 other device also cites its predicate K041649.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 FX Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The FX Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060747 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060747: FX Detachable Coil System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060747
Report an extraction error
Are you the manufacturer?
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