# K964367: Ces Vascular Occlusion System

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Neurovascular, Inc.
- Decided: Jan 30, 1997 after 90 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: 1 generation back to K891688 (1989). 4 ancestors in all.
80 later devices descend from it; 3 cite it directly.
1 of 85 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901721: Modified Target Therapeutics Coils, Target Therapeutics (1990). 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”.
- K901337: Hilal Embolization Microcoil (TM), Cook, Inc. (1990). 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”.
- K891688: Coil and Coil Delivery System, Target Therapeutics (1989) Summary page 1.
- K930982: Illusion Steerable Microguidewire for Neurovac Use, Cordis Corp. (1994) Summary page 1.

## Most influential descendants
- K972881: Ces Vascular Occlusion System (1998), 79 descendants of its own
- K983483: Vascular Occlusion System (1999), 78 descendants of its own
- 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

## Indications for use
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.

Source page: https://510kreport.com/device/K964367
Methodology: https://510kreport.com/methodology