# K060927: Ceres Pta Catheter Models PTA018,PTA035 Various Sizes

- Pathway: 510(k) (Traditional)
- Applicant: Ceres Medical Systems, LLC
- Decided: Oct 6, 2006 after 185 days
- Product code: DQY (Catheter, Percutaneous)
- 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: 2 generations back to K000101 (2000). 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)
- K020854: Modification to Fox Pta Catheter, Jomed AG (2002) Summary page 1.

## Indications for use
The Ceres PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K060927
Methodology: https://510kreport.com/methodology