# K101339: Archer Super Stiff Guidewires

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Aug 31, 2010 after 111 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011906 (2001). 3 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061670: Lunderquist Wire Guide; DC Wire Guide, William Cook Europe Aps (2007) Summary page 2.
- K020283: Back-UP Meier Steerable Guidewire, Boston Scientific Corp (2002) Summary page 1.

## Most influential descendants
- K132623: Medtronic Confida Brecker Curve Guidewire (2013), 11 descendants of its own
- K150465: Medtronic Confida Brecker Guidewire (2015), 9 descendants of its own
- K181001: Medtronic Confida Brecker Guidewire (2018), 8 descendants of its own
- K192454: Wattson Temporary Pacing Guidewire (2020), 6 descendants of its own
- K213854: SavvyWire (2022), 4 descendants of its own

## Recalls of this device
- Mar 13, 2013 · Class II · Z-1017-2013: Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the w
- Mar 13, 2013 · Class II · Z-1019-2013: Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W, where a change in the ma

## Indications for use
The Medtronic Archer 0.035 inch (0.89 mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed.

Source page: https://510kreport.com/device/K101339
Methodology: https://510kreport.com/methodology