# K121051: Concierge Guiding Catheter

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jun 13, 2012 after 68 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 K033633 (2004). 2 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043387: Vascon Polaris Guiding Catheter, Vascon, LLC (2005) Summary page 1.

## Most influential descendants
- K132409: Concierge Guiding Catheter (2013), 4 descendants of its own
- K220780: ROVO Mechanical Thrombectomy Device (2023), 1 descendant of its own
- K253730: RoVo Mechanical Thrombectomy System (2026), 0 descendants of its own
- K191163: Lumax Guiding Catheter (2019), 0 descendants of its own
- K160561: Boosting Catheter (2016), 0 descendants of its own

## Indications for use
The Concierge® Guiding Catheter is intended for the intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

Source page: https://510kreport.com/device/K121051
Methodology: https://510kreport.com/methodology