510(k) · Cleared
ClearedMicrus Microcoil System, Deltapaq 10 Cerecyte, Model CDF
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 May 8, 2008 as substantially equivalent to K033813 (Micrus Corp., 2004) after an 83-day review. Its family tree reaches back 7 generations to 1995. 1 of the 38 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- May 8, 2008
- Review
- 83 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K951256 (1995). 27 ancestors in all, the oldest K860840 (1986). 10 later devices descend from it, 3 citing it directly. 1 of the 38 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 6 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 5 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 4 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 3 generations backK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
- 2 generations backK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
- 1 generation backK033813 Micrus Modified Microcoil System, CerecyteMicrus Corp. · 2004
- This deviceK080437 Micrus Microcoil System, Deltapaq 10 Cerecyte, Model CDFMicrus Endovascular Corporation · 2008
- Descendant · cites it directly · 7 of its ownK082739 Micrus Microcoil Delivery SystemMicrus Endovascular Corporation · 2008
- Descendant · 2 generations on · 5 of its ownK150319 Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT…Codman & Shurtleff, Inc. · 2015
- Descendant · 3 generations on · 2 of its ownK171862 GALAXY G3 Mini Microcoil Delivery SystemCodman & Shurtleff, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 2 of its ownK171747 MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System…Codman & Shurtleff, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK211344 MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and…Medos International SARL · 2021
Showing 5 of 10 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 10 · See all- K082739Micrus Microcoil Delivery SystemMicrus Endovascular Corporation · 2008 · cites it directly7descendants
- K150319Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch Resistant…Codman & Shurtleff, Inc. · 2015 · 2 generations on5descendants
- K171862GALAXY G3 Mini Microcoil Delivery SystemCodman & Shurtleff, Inc. · 2017 · 3 generations on2descendants
- K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…Codman & Shurtleff, Inc. · 2017 · 3 generations on2descendants
- K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini…Medos International SARL · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −6 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −5 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −4 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −3 | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… | Boston Scientific, Target | 2000 | — |
| −2 | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01 | Micrus Corp. | 2002 | — |
| −1 | K033813 | Micrus Modified Microcoil System, Cerecyte | Micrus Corp. | 2004 | — |
| 0 (this device) | K080437 | Micrus Microcoil System, Deltapaq 10 Cerecyte, Model CDF | Micrus Endovascular Corporation | 2008 | — |
| +1 | K082739 | Micrus Microcoil Delivery System | Micrus Endovascular Corporation | 2008 | — |
| +2 | K150319 | Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch… | Codman & Shurtleff, Inc. | 2015 | — |
| +3 | K171862 | GALAXY G3 Mini Microcoil Delivery System | Codman & Shurtleff, Inc. | 2017 | 1 |
| +3 | K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18… | Codman & Shurtleff, Inc. | 2017 | — |
| +3 | K211344 | MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3… | Medos International SARL | 2021 | — |
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 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 1 |
| 2026 | 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.
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? (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 |
|---|---|---|---|
| * | K033813 | Micrus Modified Microcoil System, CerecyteSummary page 1…Classification Name: Device, Neurovascular Embolization Regulatory Class II Predicate Devices: Micrus Cerecyte Microcoil, 5 10O(k) no. K03 3813 Device Description: The Micrus Deltapaq 10 Cerecyte Microcoil Systems consists of an embolic coil… | 2004 |
What descends from it? (10)
3 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 1.3 years on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K082739 (Micrus Endovascular Corporation, 2008) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K033813.
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/K080437 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080437: Micrus Microcoil System, Deltapaq 10 Cerecyte, Model CDF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080437
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