# K060224: Modification to Mira-Flex 18 Microcatheter

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Mar 6, 2006 after 35 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
No predicates in its family tree.
18 later devices descend from it; 3 cite it directly.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K072724: Cxi Support Catheter (2007), 13 descendants of its own
- K093052: Crosscath Support Cathter (2009), 7 descendants of its own
- K191731: Instylla Microcatheter (2019), 3 descendants of its own
- K080737: Miraflex High Flow Microcatheter (2008), 3 descendants of its own
- K200744: Instylla Microcatheter (2020), 2 descendants of its own

## Indications for use
The Mira-FlexTM 18 microcatheter is designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use. Supplied sterile in peel-open packages. Intended for one-time use.

Source page: https://510kreport.com/device/K060224
Methodology: https://510kreport.com/methodology