# K033633: Vascon Polaris Guiding Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vascon, LLC
- Decided: Feb 18, 2004 after 91 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cordis Guiding Catheters (Vista BRITE TIP®): named in the summary without a submission number

## Most influential descendants
- K043387: Vascon Polaris Guiding Catheter (2005), 8 descendants of its own
- K121051: Concierge Guiding Catheter (2012), 6 descendants of its own
- 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

## Indications for use
The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.

Source page: https://510kreport.com/device/K033633
Methodology: https://510kreport.com/methodology