# K072990: Guardwire Temporary Occlusion and Aspiration System- Carotid

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Oct 31, 2007 after 7 days
- Product code: NTE (Temporary Carotid Catheter For Embolic Capture)
- 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: 4 generations back to K003992 (2001). 17 ancestors in all.
8 later devices descend from it; 2 cite it directly.
2 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023878: Guardwire Temporary Occlusion and Aspiration System, Medtronic Vascular (2003) Summary page 1.
- K030201: Modification to Export Aspiration Catheter, Medtronic Vascular (2003) Summary page 1.
- K061958: Medtronic Export XT Catheter, Medtronic Vascular (2006) Summary page 1.
- K052166: Modification to:  RX Accunet Embolic Protection System, Guidant Corporation (2005) Summary page 1.
- K052659: Spiderx Embolic Protection Device, Ev3, Inc. (2006) Summary page 1.
- K052454: The Emboshield Embolic Protection System, Abbott Vascular Devices (2005) Summary page 1.

## Most influential descendants
- K083300: Gore Flow Reversal System (2009), 5 descendants of its own
- K143072: ENROUTE Transcarotid Neuroprotection System (2015), 2 descendants of its own
- K153485: ENROUTE Transcarotid Neuroprotection System (2016), 1 descendant of its own
- K082348: Fibernet Embolic Protection System (2008), 1 descendant of its own
- K230402: ENROUTE® Transcarotid Neuroprotection System (2023), 0 descendants of its own

## Indications for use
The GuardWire Temporary Occlusion and Aspiration System is indicated for use in carotid arteries to: Contain and aspirate embolic material (thrombus/debris) while performing angioplasty or stenting procedures. Facilitate placement and use of diagnostic or therapeutic catheters using the GuardWire Temporary Occlusion Catheter. To locally infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion. The diameter of the artery where the occlusion balloon is placed should be between 3 and 6 mm.

Source page: https://510kreport.com/device/K072990
Methodology: https://510kreport.com/methodology