# K032485: Medtronic Minimed Countach Infusion Set, Model 313

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed
- Decided: Oct 28, 2003 after 77 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K972135 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972135: Maersk Medical Pureline Comfort Subcutaneous Infusion Set, P/L Biomedical (1997) Summary page 1.

## Indications for use
The Countach Infusion set is intended for the subcutaneous infusion of medicine, including insulin from an infusion pump and reservoir. The set is not intended nor indicated for use with blood or blood products.

Source page: https://510kreport.com/device/K032485
Methodology: https://510kreport.com/methodology