# K182243: The CVC WAND Safety Introducer with Valved Peelable Sheath

- Pathway: 510(k) (Special)
- Applicant: Access Scientific, LLC
- Decided: Sep 18, 2018 after 29 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 K932323 (1993). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131148: The CVC Wand Safety Introducer with Valved Peelable Sheath, Access Scientific, LLC (2013) Summary page 4.

## Indications for use
The CVC WAND Safety Introducer with Valved Peelable Sheath is indicated for use in percutaneous insertion of catheters into the venous system.

Source page: https://510kreport.com/device/K182243
Methodology: https://510kreport.com/methodology