# K233268: Impress Angiographic Catheter

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: May 22, 2024 after 236 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: 4 generations back to K000659 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191608: Impress Angiographic Catheter, Merit Medical Systems, Inc. (2019) Summary page 4.
- K053171: Merit Impress Diagnostic Catheter, Merit Medical Systems, Inc. (2006) Summary page 4.

## Indications for use
The Impress Angiographic Catheter is 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/K233268
Methodology: https://510kreport.com/methodology