510(k) · Cleared
ClearedVascular 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 Mar 24, 1999 as substantially equivalent to K901337 (Cook, Inc., 1990) and 3 other predicates after a 170-day review. Its family tree reaches back 3 generations to 1989. 1 of the 86 devices in its family, counting itself, has a Class I recall. 78 later devices descend from it.
- Decided
- Mar 24, 1999
- Review
- 170 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K891688 (1989). 7 ancestors in all. 78 later devices descend from it, 4 citing it directly. 1 of the 86 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK891688 Coil and Coil Delivery SystemTarget Therapeutics · 1989
- 2 generations backK964367 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1997
- 1 generation backK972881 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1998
- This deviceK983483 Vascular Occlusion SystemCordis Neurovascular, Inc. · 1999
- Descendant · cites it directly · 41 of its ownK993455 Flipper Detachable Embolization CoilCook, Inc. · 2000
- Descendant · 2 generations on · 38 of its ownK031810 Amplatzer Vascular PlugAga Medical Corp. · 2003 · Recalled
- Descendant · cites it directly · 32 of its ownK071962 Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil…Cordis Neurovascular, Inc. · 2007
- Descendant · 2 generations on · 31 of its ownK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
- Descendant · cites it directly · 23 of its ownK071939 Hydrocoil Embolic Systems (Hes)MicroVention, Inc. · 2008
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…5 generations on · 2022
Most influential descendants
Showing 5 of 78 · See all- K993455Flipper Detachable Embolization CoilCook, Inc. · 2000 · cites it directly41descendants
- K031810Amplatzer Vascular PlugAga Medical Corp. · 2003 · 2 generations on38descendants
- K071962Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher)Cordis Neurovascular, Inc. · 2007 · cites it directly32descendants
- K073442Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008 · 2 generations on31descendants
- K071939Hydrocoil Embolic Systems (Hes)MicroVention, Inc. · 2008 · cites it directly23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K891688 | Coil and Coil Delivery System | Target Therapeutics | 1989 | — |
| −2 | K964367 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1997 | — |
| −1 | K972881 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1998 | — |
| 0 (this device) | K983483 | Vascular Occlusion System | Cordis Neurovascular, Inc. | 1999 | — |
| +1 | K993455 | Flipper Detachable Embolization Coil | Cook, Inc. | 2000 | — |
| +2 | K031810 | Amplatzer Vascular Plug | Aga Medical Corp. | 2003 | 1 |
| +1 | K071962 | Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher) | Cordis Neurovascular, Inc. | 2007 | — |
| +2 | K073442 | Micrus Microcoil Systems | Micrus Endovascular Corporation | 2008 | — |
| +1 | K071939 | Hydrocoil Embolic Systems (Hes) | MicroVention, Inc. | 2008 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K901337 | Hilal Embolization Microcoil (TM)Summary page 1…r Predicate The predicate devices are listed in the table below: Devices Device Manufacturer 510(k) Number, Product Code Concurrence Date Hilal Embolization | Cook, Inc. K901337, 11/9/90 HCG Microcoil Helix Shaped Coils | Target Therapeutics K901721, 1/8/91 HCG with Dacron Fibers Vascular Occlusion | Cordi… | 1990 |
| * | K901721 | Modified Target Therapeutics CoilsSummary page 1…Device Manufacturer 510(k) Number, Product Code Concurrence Date Hilal Embolization | Cook, Inc. K901337, 11/9/90 HCG Microcoil Helix Shaped Coils | Target Therapeutics K901721, 1/8/91 HCG with Dacron Fibers Vascular Occlusion | Cordis Endovascular | K964367, 1/30/97 HCG System Systems, Inc. K972881, 6/4/… | 1990 |
| * | K964367 | Ces Vascular Occlusion SystemSummary page 1…on | Cook, Inc. K901337, 11/9/90 HCG Microcoil Helix Shaped Coils | Target Therapeutics K901721, 1/8/91 HCG with Dacron Fibers Vascular Occlusion | Cordis Endovascular | K964367, 1/30/97 HCG System Systems, Inc. K972881, 6/4/98 Classification Class I1 Performance The FDA under Section 514 of the Food, Dr… | 1997 |
| * | K972881 | Ces Vascular Occlusion SystemSummary page 1…coil Helix Shaped Coils | Target Therapeutics K901721, 1/8/91 HCG with Dacron Fibers Vascular Occlusion | Cordis Endovascular | K964367, 1/30/97 HCG System Systems, Inc. K972881, 6/4/98 Classification Class I1 Performance The FDA under Section 514 of the Food, Drug and Cosmetic Act has not Standard esta… | 1998 |
What descends from it? (78)
See all 784 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993455 | Flipper Detachable Embolization Coil | 2000 | 41 |
| K071962 | Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher) | 2007 | 32 |
| K071939 | Hydrocoil Embolic Systems (Hes) | 2008 | 23 |
| K123560 | Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit Detachable… | 2013 | 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 · 5 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K993455 (Cook, Inc., 2000) has gone furthest, with 41 descendants of its own.
- 6 other devices also cite its predicate K901337.
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 Cordis Endovascular Systems, Inc. Vascular Occlusion System may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.
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/K983483 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983483: 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/K983483
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