510(k) · Cleared
Recalled · 2010Micrus Microcoil System Presidio-18, Model PC4
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 Aug 25, 2006 as substantially equivalent to K053160 (Micrus Endovascular Corporation, 2005) and 2 other predicates after a 37-day review. Its family tree reaches back 8 generations to 1995. 1 of the 66 devices in its family, counting itself, has a Class I recall. 34 later devices descend from it. It has been recalled once.
- Decided
- Aug 25, 2006
- Review
- 37 days
- Class
- Class II
- Product code
- HCG
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 8 generations to K951256 (1995). 31 ancestors in all, the oldest K860840 (1986). 34 later devices descend from it, 3 citing it directly. 1 of the 66 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 7 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 6 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 5 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 4 generations backK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
- 3 generations backK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
- 2 generations backK033813 Micrus Modified Microcoil System, CerecyteMicrus Corp. · 2004
- 1 generation backK053160 Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & CheMicrus Endovascular Corporation · 2005
- This deviceK062036 Micrus Microcoil System Presidio-18, Model PC4Micrus Endovascular Corporation · 2006
- Descendant · cites it directly · 32 of its ownK070707 Micrus Microcoil SystemMicrus Endovascular Corporation · 2007
- Descendant · 2 generations on · 31 of its ownK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
- Descendant · 3 generations on · 22 of its ownK081465 Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 10 of its ownK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- Descendant · 2 generations on · 7 of its ownK082739 Micrus Microcoil Delivery SystemMicrus Endovascular Corporation · 2008
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…4 generations on · 2022
Most influential descendants
Showing 5 of 34 · See all- K070707Micrus Microcoil SystemMicrus Endovascular Corporation · 2007 · cites it directly32descendants
- K073442Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008 · 2 generations on31descendants
- K081465Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · 3 generations on22descendants
- K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013 · 4 generations on10descendants
- K082739Micrus Microcoil Delivery SystemMicrus Endovascular Corporation · 2008 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −7 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −6 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −5 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −4 | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… | Boston Scientific, Target | 2000 | — |
| −3 | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01 | Micrus Corp. | 2002 | — |
| −2 | K033813 | Micrus Modified Microcoil System, Cerecyte | Micrus Corp. | 2004 | — |
| −1 | K053160 | Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & Che | Micrus Endovascular Corporation | 2005 | — |
| 0 (this device) | K062036 | Micrus Microcoil System Presidio-18, Model PC4 | Micrus Endovascular Corporation | 2006 | — |
| +1 | K070707 | Micrus Microcoil System | Micrus Endovascular Corporation | 2007 | — |
| +2 | K073442 | Micrus Microcoil Systems | Micrus Endovascular Corporation | 2008 | — |
| +3 | K081465 | Axium Detachable Coil System | Micro Therapeutics, Inc. | 2008 | 2 |
| +4 | K123803 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| +2 | K082739 | Micrus Microcoil Delivery System | Micrus Endovascular Corporation | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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? (3)
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 |
|---|---|---|---|
| * | K053160 | Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & CheSummary page 1…Product Code: HCG Device Class: II C. PredicateDevice(s) Number Description Clearance Date K053 160 Micrus MicroCoil System, Cerecyte- 18 Dec 07, 2005 K012145 MicroVention MicroPlex Complex 3D Oct 29, 2001… | 2005 |
| * | K012145 | Microplex Coil SystemSummary page 1…(s) Number Description Clearance Date K053 160 Micrus MicroCoil System, Cerecyte- 18 Dec 07, 2005 K012145 MicroVention MicroPlex Complex 3D Oct 29, 2001 K002056 Micrus MicroCoil Delivery System Jan 11, 2001… | 2001 |
| * | K002056 | Micrus Microcoil Delivery System, MDS03Summary page 1…earance Date K053 160 Micrus MicroCoil System, Cerecyte- 18 Dec 07, 2005 K012145 MicroVention MicroPlex Complex 3D Oct 29, 2001 K002056 Micrus MicroCoil Delivery System Jan 11, 2001 D. Device Description The Micrus Presidio 18-System Microcoil… | 2001 |
What descends from it? (34)
See all 343 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 21, 2010 | Not classified | Z-0845-2011 | Other | The firm has received reports of difficulty connecting to the detachment control cable. Loss of the electrical connection will result in failure to detach the coil for deployment inside an aneurysm. |
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 · 4 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 31 ancestors have a recall of any class.
- Of its descendants, K070707 (Micrus Endovascular Corporation, 2007) has gone furthest, with 32 descendants of its own.
- 2 other devices also cite its predicate K053160.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062036: Micrus Microcoil System Presidio-18, Model PC4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062036
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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