# K152054: Confida Adaptive Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Aug 7, 2015 after 15 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K032073 (2003). 12 ancestors in all.
No later device cites it as a predicate yet.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123990: Sentrant Introducer Sheath with Hydrophilic Coating, Medtronic Vascular (2013) Summary page 4.
- K141696: Edwards Esheath Introducer Set, Edwards Lifesciences (2014) Summary page 4.

## Indications for use
The Confida™ Adaptive Sheath is intended to provide a conduit through the iliofemoral vessels for the insertion of diagnostic or interventional devices used during cardiovascular procedures, including transcatheter aortic valve replacement (TAVR).

Source page: https://510kreport.com/device/K152054
Methodology: https://510kreport.com/methodology