# K053171: Merit Impress Diagnostic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jan 19, 2006 after 66 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: 1 generation back to K000659 (2000). 2 ancestors in all.
10 later devices descend from it; 5 cite it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000659: Modification to Softouch Diagnostic Intravascular Cat, Merit Medical Systems, Inc. (2000) Summary page 1.
- K001578: Angiodynamics Soft-VU Hydrophilic Coated Angiographic Catheter, AngioDynamics, Inc. (2000) Summary page 2.

## Most influential descendants
- K093004: Impress Angiographic Catheter with Hydrophilic Coating (2010), 4 descendants of its own
- K120158: Coronary Sinus Guide and Lateral Vein Introducer Kits (2012), 3 descendants of its own
- K191608: Impress Angiographic Catheter (2019), 2 descendants of its own
- K152116: 5.5 F Worley Advanced LVI Lateral Vein Introducer (2015), 1 descendant of its own
- K260459: VANES Delivery System (VDS) (2026), 0 descendants of its own

## Indications for use
Angiography 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/K053171
Methodology: https://510kreport.com/methodology