# K170636: Fathom-16 Steerable Guidewires

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Mar 22, 2017 after 20 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K111485 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111485: Fathom 16 Steerable Guidewire Model M001509XXX, Boston Scientific Corporation (2011) Summary page 4.

## Indications for use
The FATHOM -16 Steerable Guidewire is intended for general intravascular use in the peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Source page: https://510kreport.com/device/K170636
Methodology: https://510kreport.com/methodology