# K014223: Modification to Guardwire Plus Temporary Occlusion & Aspiration System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Percusurge, Inc.
- Decided: Jan 25, 2002 after 30 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
No predicates in its family tree.
98 later devices descend from it; 2 cite it directly.
3 of 99 devices in its family (counting itself) have 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
- K030201: Modification to Export Aspiration Catheter (2003), 60 descendants of its own
- K040869: Export Catheter (2004), 59 descendants of its own
- K023691: Boston Scientific Filterwire EX Embolic (2003), 48 descendants of its own
- K032884: Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath (2004), 35 descendants of its own
- K061958: Medtronic Export XT Catheter (2006), 30 descendants of its own

## Indications for use
The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts to: Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures. To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion. 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/K014223
Methodology: https://510kreport.com/methodology