# K011906: Back-UP Meier Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Aug 13, 2001 after 55 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Platinum Plus Guidewire: named in the summary without a submission number
- (no number) Amplatz Super Stiff Guidewire: named in the summary without a submission number

## Most influential descendants
- K020283: Back-UP Meier Steerable Guidewire (2002), 14 descendants of its own
- K101339: Archer Super Stiff Guidewires (2010), 13 descendants of its own
- 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

## Recalls of this device
- Apr 19, 2010 · Not classified · Z-1760-2010: Boston Scientific Corporation is conducting a Medical Device Recall of certain lots/batches of its Back-up Meier Steerable Guidewires. Through their internal inspection process, they identified that t

## Indications for use
The Back-Up Meier Guidewire is intended to facilitate placement of a catheter during diagnostic or interventional intravascular procedures.

Source page: https://510kreport.com/device/K011906
Methodology: https://510kreport.com/methodology