# K042489: 6F Z4 Guide Catheter

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Dec 13, 2004 after 90 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 191 (191 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K981198 (1998). 3 ancestors in all.
8 later devices descend from it; 4 cite it directly.
3 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021256: Z3 Guide Catheter, Medtronic Vascular (2002) Summary page 1.

## Most influential descendants
- K060418: 8F Sherpa NX Guide Catheter (2006), 3 descendants of its own
- K062420: 5F Sherpa Active NX Guide Catheter (2006), 2 descendants of its own
- K083422: 6F Taiga Guiding Catheter (2009), 1 descendant of its own
- K051846: 7F Sherpa NX Guide Catheter (2005), 1 descendant of its own
- K232190: 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter (2023), 0 descendants of its own

## Recalls of this device
- Mar 15, 2019 · Class I · Z-2657-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2632-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2748-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2587-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2594-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2665-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2661-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2576-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2742-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2679-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2716-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2655-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2642-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2569-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2714-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2577-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2584-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2704-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2629-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2751-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2603-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2703-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2595-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2690-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2695-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2667-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2578-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2746-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2648-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2621-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2701-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2693-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2645-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2698-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2743-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2708-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2729-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2562-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2623-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2620-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2619-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2653-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2669-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2618-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2624-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2641-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2640-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2702-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2734-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Mar 15, 2019 · Class I · Z-2582-2019: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

## Indications for use
The Medtronic 6F Sherpa NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Sherpa NX guiding catheter is intended for used in the coronary or peripheral vascular system.

Source page: https://510kreport.com/device/K042489
Methodology: https://510kreport.com/methodology