# K213834: Cardio Flow Peripheral Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Cardio Flow Inc.,
- Decided: Mar 18, 2022 after 99 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: 11 generations back to K890505 (1989). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103057: Asahi Astato XS 20 Peripheral Guide Wire, Asahi Intecc Co., Ltd. (2010) Summary page 4.
- K153443: ASAHI Astato XS 40, Asahi Intecc Co., Ltd. (2016) Summary page 5.

## Indications for use
The Cardio Flow Peripheral Guide Wire is intended for temporary placement in peripheral vasculature to facilitate the placement and exchange of diagnostic and therapeutic devices during percutaneous intravascular procedures. This guidewire device is intended for peripheral vascular use only.

Source page: https://510kreport.com/device/K213834
Methodology: https://510kreport.com/methodology