# K994141: Catheter, Intravascular Occluding, Temporary, Model Sol 3510; Wire, Guide, Catheter, Model QSW1000

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Ave, Inc.
- Decided: Jul 21, 2000 after 226 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 K982543 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990487: Equinox Occlusion Balloon System, Micro Therapeutics, Inc. (1999) Summary page 2.
- K982543: Silverstreak Hydrophilic Guidewire, Micro Therapeutics, Inc. (1998) Summary page 2.

## Indications for use
The Medtronic AVE Solstice™ Solstice Balloon Temporary Occlusion System is intended to be used for temporary vascular occlusion in selectively stopping or controlling blood flow in the peripheral, cerebral, and visceral vasculature.

Source page: https://510kreport.com/device/K994141
Methodology: https://510kreport.com/methodology