# K140557: Mivi 6F Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Mivi, LLC
- Decided: Sep 18, 2014 after 197 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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 K003880 (2001). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110483: Modified HD Guide Catheter, Concentric Medical, Inc. (2011) Summary page 4.
- (no number) Stryker Concentric Distal Access Catheters Models 90120, 90121, 90130, 90131, 90160, 90161 and 90162: named in the summary without a submission number

## Most influential descendants
- K151396: MIVI Mi-AXUS Guide Catheter (2015), 1 descendant of its own
- K201076: Anchor Dual Lumen Guidewire Catheter (2020), 0 descendants of its own

## Indications for use
The MiVi 6F Guide Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter.

Source page: https://510kreport.com/device/K140557
Methodology: https://510kreport.com/methodology