# K242169: Morph DNA Steerable Introducer Sheath

- Pathway: 510(k) (Special)
- Applicant: Biocardia
- Decided: Aug 23, 2024 after 30 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: 5 generations back to K931794 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192774: BioCardia 8F Morph DNA Deflectable Guide Catheter, Biocardia (2020) Summary page 4.

## Indications for use
The Morph DNA Steerable Introducer Sheath is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.

Source page: https://510kreport.com/device/K242169
Methodology: https://510kreport.com/methodology