# K032553: Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known as Trufill DCS Orbit Detachable Coil System

- Pathway: 510(k) (Special)
- Applicant: Cordis Neurovascular, Inc.
- Decided: Sep 23, 2003 after 35 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
No predicates in its family tree.
37 later devices descend from it; 2 cite it directly.
1 of 38 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K063653: Micrus Microcoil System, Cashmere Model SRC (2007), 35 descendants of its own
- K070707: Micrus Microcoil System (2007), 32 descendants of its own
- 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

## Indications for use
The TRUFILL@DCS Detachable Coil is indicated for embolizing certain intracranial aneurysms that, because of their morphology, location, or the patient's general medical condition, are considered by the treating neurosurgical team to be: 1) very high-risk for management by traditional operative techniques 2) inoperable and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL@ DCS Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature. The TRUFILL@DCS Syringe is indicated for use with the TRUFILLO family of Detachable Coils.

Source page: https://510kreport.com/device/K032553
Methodology: https://510kreport.com/methodology