# K031357: Guarddog Occlusion System, Occlusion Guidewire, 300 CM, Guarddog Occlusion System Occlusion Guidewire, 200 CM

- Pathway: 510(k) (Traditional)
- Applicant: Possis Medical, Inc.
- Decided: May 18, 2004 after 384 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: 1 generation back to K972777 (1998). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972777: Temporary Occlusion Balloon System, Percu Surge, Inc. (1998) Summary page 1.
- K990487: Equinox Occlusion Balloon System, Micro Therapeutics, Inc. (1999) Summary page 1.

## Most influential descendants
- K062220: Modification to Guarddog Occlusion System (2006), 1 descendant of its own
- K081454: Guarddog Occlusion Guidewire, Inflation Device (2008), 0 descendants of its own

## Indications for use
The GuardDOGTM 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/K031357
Methodology: https://510kreport.com/methodology