# K233975: Zoom 6F Insert Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Imperative Care, Inc.
- Decided: Apr 2, 2024 after 109 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.

## Indications for use
The Zoom 6F Insert Catheters are indicated for use in delivering radiopaque media to selected sites in the peripheral vascular system in conjunction with routine diagnostic procedures.

Source page: https://510kreport.com/device/K233975
Methodology: https://510kreport.com/methodology