# K023878: Guardwire Temporary Occlusion and Aspiration System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Jan 24, 2003 after 64 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.
28 later devices descend from it; 4 cite it directly.
3 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Guardwire Temporary Occlusion and Aspiration System: named in the summary without a submission number

## Most influential descendants
- K053195: Spiderx Embolic Protection Device (2006), 14 descendants of its own
- K062201: Spiderx Embolic Protection Device (2006), 13 descendants of its own
- K063785: Spiderfx Embolic Protection Device (2007), 12 descendants of its own
- K090364: Extra Pta Balloon Catheter with Embolic Protection Feature (2010), 10 descendants of its own
- K072990: Guardwire Temporary Occlusion and Aspiration System- Carotid (2007), 8 descendants of its own

## Indications for use
The Guardwire 3-6 Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts to: Contain and aspirate embolic material (thrombuddebris) 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/K023878
Methodology: https://510kreport.com/methodology