# K123560: Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit Detachable Coil Sysem

- Pathway: 510(k) (Special)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Jan 25, 2013 after 67 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964367: Ces Vascular Occlusion System, Cordis Neurovascular, Inc. (1997) Summary page 1.
- K972881: Ces Vascular Occlusion System, Cordis Neurovascular, Inc. (1998) Summary page 1.
- K983483: Vascular Occlusion System, Cordis Neurovascular, Inc. (1999) Summary page 1.
- K030963: Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known as the Trufill DCS Orbit Detachable Coil System, Cordis Neurovascular, Inc. (2003) Summary page 2.
- K032553: Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known as Trufill DCS Orbit Detachable Coil System, Cordis Neurovascular, Inc. (2003) Summary page 2.
- K053197: Trufill DCS Orbit Detachable Coil System Line Extension, Cordis Neurovascular, Inc. (2005) Summary page 2.
- K080967: Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill DCS Syringe II, Also Known as the Trufill DCS Orbit, Cordis Neurovascular, Inc. (2008) Summary page 2.

## Indications for use
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 df the brain, spinal cord and spine. The TRUFILL DOS ORBIT Detachable Coil System is indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL DOS ORBIT Detachable Coil is also intended for arterial and venous embolization in the peripheral vasculature.

Source page: https://510kreport.com/device/K123560
Methodology: https://510kreport.com/methodology