# K132673: 5F & 6F Launcher Guide Catheter, 5F Sherpa Active NX Guide Catheter, 6F Z4 Guiding Catheter

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Oct 22, 2013 after 56 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: 6 generations back to K981198 (1998). 10 ancestors in all.
No later device cites it as a predicate yet.
2 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103386: Medtronic Vascular - Hub Material Modification to the 5F and 8F Launcher (R) Guide Catheters, Medtronic, Inc. (2011) Summary page 2.
- K021256: Z3 Guide Catheter, Medtronic Vascular (2002) Summary page 2.
- K062420: 5F Sherpa Active NX Guide Catheter, Medtronic Vascular (2006) Summary page 2.
- K042489: 6F Z4 Guide Catheter, Medtronic Vascular (2004) Summary page 2.

## 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 Guide Catheters are intended to be used in the coronary or the peripheral system: and are designed to provide a pathway through which therapeutic devices are introduced.

Source page: https://510kreport.com/device/K132673
Methodology: https://510kreport.com/methodology