# K080737: Miraflex High Flow Microcatheter

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Aug 8, 2008 after 144 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: 1 generation back to K060224 (2006). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060224: Modification to Mira-Flex 18 Microcatheter, Cook Incorporated (2006) Summary page 1.

## Most influential descendants
- K101450: Cantata Microcatheter (2010), 2 descendants of its own
- K131772: Cantata (R) 2.9 Microcatheter (2014), 1 descendant of its own
- K191305: Hereaeus Poseidon Microcatheter (2019), 0 descendants of its own

## Indications for use
The MiraFlexTM High Flow Microcatheter is designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.

Source page: https://510kreport.com/device/K080737
Methodology: https://510kreport.com/methodology