# K213435: MAGIC Flow-Dependent Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Balt USA, LLC
- Decided: Jul 19, 2022 after 270 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K923368 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202366: MAGIC Infusion Catheter, Balt USA, LLC (2021) Summary page 4.

## Indications for use
The MAGIC Flow-Dependent Microcatheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified embolization materials and diagnostic materials such as contrast media.

Source page: https://510kreport.com/device/K213435
Methodology: https://510kreport.com/methodology