# K180959: Phenom 27 Catheter

- Pathway: 510(k) (Special)
- Applicant: Cathera, Inc.
- Decided: Jun 11, 2018 after 60 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: 5 generations back to K945904 (1995). 11 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151638: Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter, Cathera, Inc. (2015) Summary page 4.

## Most influential descendants
- K210230: Phenom Catheters (2021), 2 descendants of its own
- K260199: SLIM Microcatheter (2026), 0 descendants of its own
- K251668: SurfRider 13 Microcatheter (2026), 0 descendants of its own
- K222023: RayFlow (2023), 0 descendants of its own

## Indications for use
Phenom® Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.

Source page: https://510kreport.com/device/K180959
Methodology: https://510kreport.com/methodology