# K090621: Flowcardia Flowmater Injector, Model Inj 100

- Pathway: 510(k) (Traditional)
- Applicant: Flowcardia, Inc.
- Decided: Jun 19, 2009 after 102 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- 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 K903390 (1990). 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)
- K903390: Medrad Mark V-Plus Injector, Medrad, Inc. (1990) Summary page 2.

## Indications for use
The FlowCardia FlowMate Injector is intended for use as a sterile saline injector for use as an accessory to the FlowCardia CROSSER CTO Recanalization System.

Source page: https://510kreport.com/device/K090621
Methodology: https://510kreport.com/methodology