510(k) · Cleared
ClearedMicrus Microcoil Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micrus Endovascular Corporation · HCG Device, Neurovascular Embolization
Cleared on Feb 26, 2008 as substantially equivalent to K070707 (Micrus Endovascular Corporation, 2007) and 3 other predicates after an 81-day review. Its family tree reaches back 10 generations to 1995. 1 of the 80 devices in its family, counting itself, has a Class I recall. 31 later devices descend from it.
- Decided
- Feb 26, 2008
- Review
- 81 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K951256 (1995). 48 ancestors in all, the oldest K860840 (1986). 31 later devices descend from it, 3 citing it directly. 1 of the 80 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 6 generations between
- 3 generations backK053160 Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & CheMicrus Endovascular Corporation · 2005
- 2 generations backK062036 Micrus Microcoil System Presidio-18, Model PC4Micrus Endovascular Corporation · 2006 · Recalled
- 1 generation backK070707 Micrus Microcoil SystemMicrus Endovascular Corporation · 2007
- This deviceK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
- 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 · cites it directly · 7 of its ownK082739 Micrus Microcoil Delivery SystemMicrus Endovascular Corporation · 2008
- 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
Show all 10 generations
- Root · 10 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 9 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 8 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 7 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 6 generations backK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
- 5 generations backK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
- 4 generations backK033813 Micrus Modified Microcoil System, CerecyteMicrus Corp. · 2004
- 3 generations backK053160 Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & CheMicrus Endovascular Corporation · 2005
- 2 generations backK062036 Micrus Microcoil System Presidio-18, Model PC4Micrus Endovascular Corporation · 2006 · Recalled
- 1 generation backK070707 Micrus Microcoil SystemMicrus Endovascular Corporation · 2007
- This deviceK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…3 generations on · 2022
Most influential descendants
Showing 5 of 31 · 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
- K082739Micrus Microcoil Delivery SystemMicrus Endovascular Corporation · 2008 · cites it directly7descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −9 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −8 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −7 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −6 | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… | Boston Scientific, Target | 2000 | — |
| −5 | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01 | Micrus Corp. | 2002 | — |
| −4 | K033813 | Micrus Modified Microcoil System, Cerecyte | Micrus Corp. | 2004 | — |
| −3 | K053160 | Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & Che | Micrus Endovascular Corporation | 2005 | — |
| −2 | K062036 | Micrus Microcoil System Presidio-18, Model PC4 | Micrus Endovascular Corporation | 2006 | 1 |
| −1 | K070707 | Micrus Microcoil System | Micrus Endovascular Corporation | 2007 | — |
| 0 (this device) | K073442 | Micrus Microcoil Systems | Micrus Endovascular Corporation | 2008 | — |
| +1 | K081465 | Axium Detachable Coil System | Micro Therapeutics, Inc. | 2008 | 2 |
| +2 | K123803 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| +1 | K082739 | Micrus Microcoil Delivery System | Micrus Endovascular Corporation | 2008 | — |
| +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 | — |
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 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 1 |
| 2023 | 1 | 0 |
| 2026 | 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.
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 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 |
|---|---|---|---|
| * | K070707 | Micrus Microcoil SystemSummary page 1…(21 CFR § 882.5950) Vascular embolization device (21 CER § 870.3300) PREDICATE DEVICES Micrus® Microcoil Delivery System (reference: K070707) Micriis® Microcoil Delivery System (reference: K03 1578) Boston Scientific / Target Therapeutics, Guglielmi Detachable Coil (ref… | 2007 |
| * | K031578 | Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSRSummary page 1…ascular embolization device (21 CER § 870.3300) PREDICATE DEVICES Micrus® Microcoil Delivery System (reference: K070707) Micriis® Microcoil Delivery System (reference: K03 1578) Boston Scientific / Target Therapeutics, Guglielmi Detachable Coil (reference: K962503) Cordis Neurrovascular, Trufill DCS Detac… | 2003 |
| * | K962503 | Guglielmi Detachable CoilSummary page 1…ivery System (reference: K070707) Micriis® Microcoil Delivery System (reference: K03 1578) Boston Scientific / Target Therapeutics, Guglielmi Detachable Coil (reference: K962503) Cordis Neurrovascular, Trufill DCS Detachable Coil (reference: K07 1962) INTENDED USE The Micrus Microcoil Delivery System i… | 1996 |
| * | K071962 | Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher)Summary page 1…ference: K03 1578) Boston Scientific / Target Therapeutics, Guglielmi Detachable Coil (reference: K962503) Cordis Neurrovascular, Trufill DCS Detachable Coil (reference: K07 1962) INTENDED USE The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, othe… | 2007 |
What descends from it? (31)
See all 313 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 6 of the 48 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 K070707.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Micrus Microcoil Delivery System is intended for endovascular embolization of
intracranial aneurysms, other neurovascular abnormalities such as arteriovenous
malformations and arteriovenous fistulae, and 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/K073442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073442: Micrus Microcoil Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073442
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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