# K212615: EpiFaith CV

- Pathway: 510(k) (Traditional)
- Applicant: Flat Medical Co., Ltd.
- Decided: Sep 21, 2022 after 399 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K884490 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884490: Introducer Safety Syringe, Arrow Intl., Inc. (1989) Summary page 5.

## Indications for use
The EpiFaith CV is intended for use in central venous catheter placement procedure, which is designed to facilitate guidewire-assisted catheter placement and is compatible with guidewires ranging from 0.025"(0.64mm) to 0.038"(0.96mm) along with their appropriate introducer needles. The device provides a visual cue when it hits a vessel with >50mmHg of pressure. The EpiFaith CV will be sold sterile individually packaged, and as part of a sterile kit. Neonates and infants shall be excluded from the intended population.

Source page: https://510kreport.com/device/K212615
Methodology: https://510kreport.com/methodology