# K032497: Sapphire VDS Tension Safe Detachable Coil, E-3-12/3-T10-VT

- Pathway: 510(k) (Special)
- Applicant: Micro Therapeutics, Inc.
- Decided: Sep 25, 2003 after 43 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K023418: Heartone Event Recorder and Transmitter, Aerotel Medical Systems (1998), Ltd. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Sapphire Detachable Coils are intended for the endovascular embolization of intracranial aneurysms that - because of their morphology, their location, or the patient’s general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) be inoperable.

Source page: https://510kreport.com/device/K032497
Methodology: https://510kreport.com/methodology