# K073523: Interceptor Plus Coronary Filter Systems

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Aug 1, 2008 after 231 days
- Product code: NFA (Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K003992 (2001). 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)
- K061332: Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM), Boston Scientific Corp (2006) Summary page 1.
- K052280: Filterwire EZ Embolic Protection System, Boston Scientific Corp (2005) Summary page 1.
- K063785: Spiderfx Embolic Protection Device, Ev3, Inc. (2007) Summary page 1.
- K013913: Percusurge Guardwire Plus Temporary Occlusion and Aspiration System, Medtronic Percusurge, Inc. (2002) Summary page 1.
- K023878: Guardwire Temporary Occlusion and Aspiration System, Medtronic Vascular (2003) Summary page 1.

## Indications for use
The Medtronic Interceptor® PLUS Coronary Filter System is intended for use in saphenous vein bypass grafts, with a reference vessel diameter between 2.5 mm and 5.25mm, in conjunction with percutaneous transluminal coronary intervention (PTCI) for embolic particulate capture. The Interceptor® PLUS Coronary Filter System is intended for temporary use in conjunction with other therapeutic devices and is intended to be removed at the completion of the interventional procedure. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature

Source page: https://510kreport.com/device/K073523
Methodology: https://510kreport.com/methodology