# K030201: Modification to Export Aspiration Catheter

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Mar 26, 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
Longest line of descent: 1 generation back to K010579 (2001). 4 ancestors in all.
60 later devices descend from it; 2 cite it directly.
2 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023303: Export Aspiration Catheter, Medtronic Vascular (2002)
- K014223: Modification to Guardwire Plus Temporary Occlusion & Aspiration System, Medtronic Percusurge, Inc. (2002) Summary page 7.
- K013913: Percusurge Guardwire Plus Temporary Occlusion and Aspiration System, Medtronic Percusurge, Inc. (2002)
- K010579: Stent Support Guide Catheter, Medtronic Vascular (2001)

## Most influential descendants
- 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
- K071727: QXT Extraction Catheter (2007), 12 descendants of its own

## Indications for use
The indication for use for the stand-alone Export Catheter is: The Export Aspiration Catheter is indicated for use with the GuardWire Temporary Occlusion and Aspiration System in 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. When the proposed modified device is included in the Guardwire 2.5-5 Temporary Occlusion and Aspiration System cleared under K013913 the indications for that system will not change. This system will be labeled as shown below: The PercuSurge Guardwire Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts (2.5-5.0mm) 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. 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. When the proposed device is included in the Guardwire 3-6 Temporary Occlusion and Aspiration System (cleared under K003992 and K014223) the indications for that system will not change. This system will be labeled as shown below: The PercuSurge Guardwire 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/K030201
Methodology: https://510kreport.com/methodology