# K080583: Modified HD Guide Catheter

- Pathway: 510(k) (Special)
- Applicant: Concentric Medical, Inc.
- Decided: Jul 18, 2008 after 137 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: 1 generation back to K003880 (2001). 1 ancestor in all.
38 later devices descend from it; 3 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003880: Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F), Concentric Medical, Inc. (2001) Summary page 1.

## Most influential descendants
- K090335: HD Guide Catheter (2009), 36 descendants of its own
- K110483: Modified HD Guide Catheter (2011), 32 descendants of its own
- K133177: Modified HD Guide Catheter (2014), 28 descendants of its own
- K151667: AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm (2015), 26 descendants of its own
- K180715: React 68 Catheter (2018), 19 descendants of its own

## 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/K080583
Methodology: https://510kreport.com/methodology