# K253526: NAMIC Dilator and Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: Jul 29, 2026 after 258 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: 8 generations back to K011084 (2001). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171275: Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design,  Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design, Cook Incorporated (2017) Summary page 5.

## Indications for use
The NAMIC Dilator and Sheath are intended for the placement of wire guides up to .038 inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired.

Source page: https://510kreport.com/device/K253526
Methodology: https://510kreport.com/methodology