# K000659: Modification to Softouch Diagnostic Intravascular Cat

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Mar 29, 2000 after 30 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 5 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K053171: Merit Impress Diagnostic Catheter (2006), 10 descendants of its own
- 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
- K062627: Innerchange Micro-Introducer Catheter, Models 7900 Through 7905 (2007), 2 descendants of its own

## Recalls of this device
- May 5, 2010 · Not classified · Z-1731-2010: Marker bands on angiographic catheters may not be properly attached, allowing movement of the bands.

Source page: https://510kreport.com/device/K000659
Methodology: https://510kreport.com/methodology