# K081454: Guarddog Occlusion Guidewire, Inflation Device

- Pathway: 510(k) (Special)
- Applicant: Possis Medical, Inc.
- Decided: Jun 13, 2008 after 21 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K972777 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062220: Modification to Guarddog Occlusion System, Possis Medical, Inc. (2006) Summary page 1.

## Indications for use
The GuardDOG Occlusion System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion. The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature.

Source page: https://510kreport.com/device/K081454
Methodology: https://510kreport.com/methodology