# K092298: Modification to Modified HD Guide Catheter

- Pathway: 510(k) (Special)
- Applicant: Concentric Medical, Inc.
- Decided: Nov 5, 2009 after 99 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 K003880 (2001). 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)
- K080583: Modified HD Guide Catheter, Concentric Medical, Inc. (2008) Summary page 1.

## Indications for use
The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic angiographic catheter.

Source page: https://510kreport.com/device/K092298
Methodology: https://510kreport.com/methodology