# K983483: Vascular Occlusion System

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Neurovascular, Inc.
- Decided: Mar 24, 1999 after 170 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K891688 (1989). 7 ancestors in all.
78 later devices descend from it; 4 cite it directly.
1 of 86 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901337: Hilal Embolization Microcoil (TM), Cook, Inc. (1990) Summary page 1.
- K901721: Modified Target Therapeutics Coils, Target Therapeutics (1990) Summary page 1.
- K964367: Ces Vascular Occlusion System, Cordis Neurovascular, Inc. (1997) Summary page 1.
- K972881: Ces Vascular Occlusion System, Cordis Neurovascular, Inc. (1998) Summary page 1.

## Most influential descendants
- K993455: Flipper Detachable Embolization Coil (2000), 41 descendants of its own
- K031810: Amplatzer Vascular Plug (2003), 38 descendants of its own
- K071962: Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher) (2007), 32 descendants of its own
- K073442: Micrus Microcoil Systems (2008), 31 descendants of its own
- K071939: Hydrocoil Embolic Systems (Hes) (2008), 23 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K983483
Methodology: https://510kreport.com/methodology