510(k) · Cleared
ClearedMicrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch Resistant Microcoil Delivery Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · HCG Device, Neurovascular Embolization
Cleared on Jun 12, 2015 as substantially equivalent to K082739 (Micrus Endovascular Corporation, 2008) after a 123-day review. Its family tree reaches back 12 generations to 1995. 1 of the 59 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Jun 12, 2015
- Review
- 123 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K951256 (1995). 53 ancestors in all, the oldest K860840 (1986). 5 later devices descend from it, 4 citing it directly. 1 of the 59 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 8 generations between
- 3 generations backK070707 Micrus Microcoil SystemMicrus Endovascular Corporation · 2007
- 2 generations backK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
- 1 generation backK082739 Micrus Microcoil Delivery SystemMicrus Endovascular Corporation · 2008
- This deviceK150319 Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT…Codman & Shurtleff, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK171862 GALAXY G3 Mini Microcoil Delivery SystemCodman & Shurtleff, Inc. · 2017 · Recalled
- Descendant · cites it directly · 2 of its ownK171747 MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System…Codman & Shurtleff, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK211344 MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and…Medos International SARL · 2021
- Descendant · 2 generations on · 0 of its ownK262419 Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe…Cerenovus, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK220040 CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform…Medos International SARL · 2022 · Recalled (Class I)
Show all 12 generations
- Root · 12 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 11 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 10 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 9 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 8 generations backK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
- 7 generations backK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
- 6 generations backK033813 Micrus Modified Microcoil System, CerecyteMicrus Corp. · 2004
- 5 generations backK053160 Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & CheMicrus Endovascular Corporation · 2005
- 4 generations backK062036 Micrus Microcoil System Presidio-18, Model PC4Micrus Endovascular Corporation · 2006 · Recalled
- 3 generations backK070707 Micrus Microcoil SystemMicrus Endovascular Corporation · 2007
- 2 generations backK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
- 1 generation backK082739 Micrus Microcoil Delivery SystemMicrus Endovascular Corporation · 2008
- This deviceK150319 Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT…Codman & Shurtleff, Inc. · 2015
Class I recalls in this family
- K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…cites it directly · 2022
Most influential descendants
Showing 5 of 5 · See all- K171862GALAXY G3 Mini Microcoil Delivery SystemCodman & Shurtleff, Inc. · 2017 · cites it directly2descendants
- K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…Codman & Shurtleff, Inc. · 2017 · cites it directly2descendants
- K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini…Medos International SARL · 2021 · cites it directly1descendant
- K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…Cerenovus, Inc. · 2026 · 2 generations on0descendants
- K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL…Medos International SARL · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −11 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −10 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −9 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −8 | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… | Boston Scientific, Target | 2000 | — |
| −7 | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01 | Micrus Corp. | 2002 | — |
| −6 | K033813 | Micrus Modified Microcoil System, Cerecyte | Micrus Corp. | 2004 | — |
| −5 | K053160 | Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & Che | Micrus Endovascular Corporation | 2005 | — |
| −4 | K062036 | Micrus Microcoil System Presidio-18, Model PC4 | Micrus Endovascular Corporation | 2006 | 1 |
| −3 | K070707 | Micrus Microcoil System | Micrus Endovascular Corporation | 2007 | — |
| −2 | K073442 | Micrus Microcoil Systems | Micrus Endovascular Corporation | 2008 | — |
| −1 | K082739 | Micrus Microcoil Delivery System | Micrus Endovascular Corporation | 2008 | — |
| 0 (this device) | K150319 | Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch… | Codman & Shurtleff, Inc. | 2015 | — |
| +1 | K171862 | GALAXY G3 Mini Microcoil Delivery System | Codman & Shurtleff, Inc. | 2017 | 1 |
| +1 | K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18… | Codman & Shurtleff, Inc. | 2017 | — |
| +1 | K211344 | MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3… | Medos International SARL | 2021 | — |
| +2 | K262419 | Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305)… | Cerenovus, Inc. | 2026 | — |
| +1 | K220040 | CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft… | Medos International SARL | 2022 | Class I |
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 | 3 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K082739 | Micrus Microcoil Delivery SystemSummary page 4…Micrus Endovascular 10/17/2008 Micrus Microcoil Delivery System** K082739 Corporation*… | 2008 |
| † | K083646 | Micrus Microcoli System, Deltaplush, Models CPL, DPL | 2009 |
| † | K033813 | Micrus Modified Microcoil System, Cerecyte | 2004 |
| † | K053160 | Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & Che | 2005 |
| † | K062036 | Micrus Microcoil System Presidio-18, Model PC4 | 2006 |
| † | K072173 | Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-SR, Model SRC | 2007 |
| † | K080437 | Micrus Microcoil System, Deltapaq 10 Cerecyte, Model CDF | 2008 |
| † | K073442 | Micrus Microcoil Systems | 2008 |
| † | K120686 | Orbit Galaxy G2 Microcoil Delivery System | 2012 |
| † | K120274 | Deltamaxx 18 Microcoil System | 2012 |
| † | K142429 | CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2… | 2014 |
| † | K093973 | Trufill DCS Orbit Detachable Coil System | 2010 |
| † | K132281 | ReVive PV (Peripheral Vasculature) Thrombectomy Device | 2013 |
| † | K140080 | Envoy Distal Access (DA) Guiding Catheter, 6F, 95CM & 105CM, Straight & XB, MPD & XB… | 2014 |
| † | K123377 | Target Detachable Coil | 2012 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171862 | GALAXY G3 Mini Microcoil Delivery System | 2017 | 2 |
| K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch… | 2017 | 2 |
| K211344 | MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini… | 2021 | 1 |
| K220040 | CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL… Class I | 2022 | 0 |
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 · Cites it directly · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 7 of the 53 ancestors have a recall of any class.
- Of its descendants, K171862 (Codman & Shurtleff, Inc., 2017) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K082739.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are 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. The GALAXY G3 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular…
Read the full statement (90 words)
MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are 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.
The GALAXY G3 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
The GALAXY G3 XSFT Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150319: Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch Resistant Microcoil Delivery Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150319
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