# K191608: Impress Angiographic Catheter

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jul 16, 2019 after 29 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000659 (2000). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093004: Impress Angiographic Catheter with Hydrophilic Coating, Merit Medical Systems, Inc. (2010) Summary page 4.

## Most influential descendants
- K233268: Impress Angiographic Catheter (2024), 0 descendants of its own
- K233975: Zoom 6F Insert Catheters (2024), 0 descendants of its own

## Indications for use
Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Angiographic catheters with marker bands may also be used for anatomical measurements.

Source page: https://510kreport.com/device/K191608
Methodology: https://510kreport.com/methodology