# K013913: Percusurge Guardwire Plus Temporary Occlusion and Aspiration System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Percusurge, Inc.
- Decided: Nov 15, 2002 after 353 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.
74 later devices descend from it; 6 cite it directly.
3 of 75 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) 3-6 Guardwire Plus System: named in the summary without a submission number

## Most influential descendants
- K030201: Modification to Export Aspiration Catheter (2003), 60 descendants of its own
- K040869: Export Catheter (2004), 59 descendants of its own
- K061958: Medtronic Export XT Catheter (2006), 30 descendants of its own
- K050130: Kerberos Proximal Solutions Rispiration System (2005), 16 descendants of its own
- K050139: Modification to: Export Catheter (2005), 14 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 (2.5-5.Omm) to: Contain and aspirate embolic material (thrombusldebris) 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 the device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature. The safety and effectiveness of the device as an embolic protection system has not been established in treating patients with acute myocardial infarction. The safety and effectiveness of the device as an embolic protection system has not been established in treating native coronaries.

Source page: https://510kreport.com/device/K013913
Methodology: https://510kreport.com/methodology