510(k) · Cleared
ClearedVascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Neurovascular, Inc. · HCG Device, Neurovascular Embolization
Cleared on Sep 26, 2007 as substantially equivalent to K983483 (Cordis Neurovascular, Inc., 1999) after a 72-day review. Its family tree reaches back 4 generations to 1989. 1 of the 41 devices in its family, counting itself, has a Class I recall. 32 later devices descend from it.
- Decided
- Sep 26, 2007
- Review
- 72 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K891688 (1989). 8 ancestors in all. 32 later devices descend from it, 1 citing it directly. 1 of the 41 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK891688 Coil and Coil Delivery SystemTarget Therapeutics · 1989
- 3 generations backK964367 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1997
- 2 generations backK972881 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1998
- 1 generation backK983483 Vascular Occlusion SystemCordis Neurovascular, Inc. · 1999
- This deviceK071962 Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil…Cordis Neurovascular, Inc. · 2007
- Descendant · cites it directly · 31 of its ownK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
- Descendant · 2 generations on · 22 of its ownK081465 Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · Recalled
- Descendant · 3 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
- Descendant · 3 generations on · 6 of its ownK133310 Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014
Showing 5 of 32 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 32 · See all- K073442Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008 · cites it directly31descendants
- K081465Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · 2 generations on22descendants
- K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013 · 3 generations on10descendants
- K082739Micrus Microcoil Delivery SystemMicrus Endovascular Corporation · 2008 · 2 generations on7descendants
- K133310Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2014 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K891688 | Coil and Coil Delivery System | Target Therapeutics | 1989 | — |
| −3 | K964367 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1997 | — |
| −2 | K972881 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1998 | — |
| −1 | K983483 | Vascular Occlusion System | Cordis Neurovascular, Inc. | 1999 | — |
| 0 (this device) | K071962 | Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher) | Cordis Neurovascular, Inc. | 2007 | — |
| +1 | K073442 | Micrus Microcoil Systems | Micrus Endovascular Corporation | 2008 | — |
| +2 | K081465 | Axium Detachable Coil System | Micro Therapeutics, Inc. | 2008 | 2 |
| +3 | K123803 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| +2 | K082739 | Micrus Microcoil Delivery System | Micrus Endovascular Corporation | 2008 | — |
| +3 | K133310 | Axium Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 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? (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 |
|---|---|---|---|
| * | K983483 | Vascular Occlusion SystemSummary page 2…dicates) TRUPUSIH Cordis - Intended Use Coil Pusher Neurovascular, K983483 HCG - Design Inc. -… | 1999 |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073442 | Micrus Microcoil Systems | 2008 | 31 |
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 · 4 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 7.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K073442 (Micrus Endovascular Corporation, 2008) has gone furthest, with 31 descendants of its own.
- 3 other devices also cite its predicate K983483.
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 intended use of the TRUFILL® Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher) is as follows:
Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071962: Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071962
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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