# K262165: FARADRIVE™ Steerable Sheath (M004PF21M402)

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Jul 24, 2026 after 28 days
- Product code: DRA (Catheter, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K070357 (2007). 9 ancestors in all.
No later device cites it as a predicate yet.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233248: FARADRIVE™ Steerable Sheath, Boston Scientific Corporation (2023) Summary page 6.

## Indications for use
The FARADRIVE Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K262165
Methodology: https://510kreport.com/methodology