# K071962: Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher)

- Pathway: 510(k) (Special)
- Applicant: Cordis Neurovascular, Inc.
- Decided: Sep 26, 2007 after 72 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: 4 generations back to K891688 (1989). 8 ancestors in all.
32 later devices descend from it; 1 cites it directly.
1 of 41 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983483: Vascular Occlusion System, Cordis Neurovascular, Inc. (1999) Summary page 2.

## Most influential descendants
- K073442: Micrus Microcoil Systems (2008), 31 descendants of its own
- K081465: Axium Detachable Coil System (2008), 22 descendants of its own
- K123803: Reverse Medical Micro Vascular Plug (MVP) System (2013), 10 descendants of its own
- K082739: Micrus Microcoil Delivery System (2008), 7 descendants of its own
- K133310: Axium Detachable Coil System (2014), 6 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K071962
Methodology: https://510kreport.com/methodology