# K250972: Primum Hydrophilic Guiding Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Pendracare
- Decided: Jun 29, 2025 after 90 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: 4 generations back to K981198 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120585: Convey Guiding Catheter, Pendracare International, B.V. (2012) Summary page 6.

## Indications for use
The Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The Guiding Catheter is intended to be used in the coronary or peripheral vascular system.

Source page: https://510kreport.com/device/K250972
Methodology: https://510kreport.com/methodology