# K161967: FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm

- Pathway: 510(k) (Traditional)
- Applicant: Callisyn Biomedical, Inc.
- Decided: Jan 27, 2017 after 193 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: 6 generations back to K961923 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033913: Progreat, Terumo Medical Corp. (2004) Summary page 4.

## Indications for use
The FluidiTube® 2.7F Infusion Micro Catheter is intended to facilitate infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, visceral vessels and all coronary vessels. It is also intended for drug infusion in intra-arterial therapy and embolic materials for hemostasis. The FluidiTube® 2.7F Infusion Micro Catheter is not to be used in cerebral blood vessels.

Source page: https://510kreport.com/device/K161967
Methodology: https://510kreport.com/methodology