510(k) · Cleared
ClearedCes Vascular Occlusion System
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 Jan 30, 1997 as substantially equivalent to K901721 (Target Therapeutics, 1990) and 3 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1989. 1 of the 85 devices in its family, counting itself, has a Class I recall. 80 later devices descend from it.
- Decided
- Jan 30, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K891688 (1989). 4 ancestors in all. 80 later devices descend from it, 3 citing it directly. 1 of the 85 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK891688 Coil and Coil Delivery SystemTarget Therapeutics · 1989
- This deviceK964367 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1997
- Descendant · cites it directly · 79 of its ownK972881 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1998
- Descendant · cites it directly · 78 of its ownK983483 Vascular Occlusion SystemCordis Neurovascular, Inc. · 1999
- Descendant · 2 generations on · 41 of its ownK993455 Flipper Detachable Embolization CoilCook, Inc. · 2000
- Descendant · 3 generations on · 38 of its ownK031810 Amplatzer Vascular PlugAga Medical Corp. · 2003 · Recalled
- Descendant · 2 generations on · 32 of its ownK071962 Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil…Cordis Neurovascular, Inc. · 2007
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…6 generations on · 2022
Most influential descendants
Showing 5 of 80 · See all- K972881Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1998 · cites it directly79descendants
- K983483Vascular Occlusion SystemCordis Neurovascular, Inc. · 1999 · cites it directly78descendants
- K993455Flipper Detachable Embolization CoilCook, Inc. · 2000 · 2 generations on41descendants
- K031810Amplatzer Vascular PlugAga Medical Corp. · 2003 · 3 generations on38descendants
- K071962Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher)Cordis Neurovascular, Inc. · 2007 · 2 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891688 | Coil and Coil Delivery System | Target Therapeutics | 1989 | — |
| 0 (this device) | K964367 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1997 | — |
| +1 | K972881 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1998 | — |
| +1 | K983483 | Vascular Occlusion System | Cordis Neurovascular, Inc. | 1999 | — |
| +2 | K993455 | Flipper Detachable Embolization Coil | Cook, Inc. | 2000 | — |
| +3 | K031810 | Amplatzer Vascular Plug | Aga Medical Corp. | 2003 | 1 |
| +2 | K071962 | Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher) | Cordis Neurovascular, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 5 | 0 |
| 2015 | 6 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 1 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K901721 | Modified Target Therapeutics Coils Our OCR of the scanned summary read K801721, FDA’s number for HSV Bio-Bead Titration Kit (Litton Bionetics). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Target Therapeutics Fibered Helical Coils”. | 1990 |
| * | K901337 | Hilal Embolization Microcoil (TM) Our OCR of the scanned summary read K801337, FDA’s number for Cyberlith IX Implantable Pulse Generator (Intermedics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Cook, Inc. Hilal Embolization Microcoil”. | 1990 |
| * | K891688 | Coil and Coil Delivery SystemSummary page 1…d Helical Coils (K801721- concurred 07/03/90) Cook, Inc. Hilal Embolization Microcoil (K801337 - concurred 11/09/90) - Target Therapeutics Helical Coils and Coil Pusher (K891688 - concurred 09/15/89) Cordis Endovascular Systems (CES), Inc. Instinct® Steerable Guidewire (K930982 - concurred 02/24/94) . Cl… | 1989 |
| * | K930982 | Illusion Steerable Microguidewire for Neurovac UseSummary page 1…rred 11/09/90) - Target Therapeutics Helical Coils and Coil Pusher (K891688 - concurred 09/15/89) Cordis Endovascular Systems (CES), Inc. Instinct® Steerable Guidewire (K930982 - concurred 02/24/94) . Classification Class lli iv. Performance Standards Performance standards have not been established by… | 1994 |
What descends from it? (80)
See all 803 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 · 6 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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?
CES Occlusion Devices may be used to reduce or block the rate of blood flow in small or tapering vessels. They are indicated for use in the interventional radiologic management of arteriovenous malformations and other vascular lesions of the brain, spinal cord and spine when devascularization prior to definitive surgical resection is desired.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964367 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964367: Ces Vascular Occlusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964367
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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