# K190126: Bendit2.7 Steerable Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Bend IT Technologies, Ltd.
- Decided: Aug 22, 2019 after 206 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K960806 (1996). 13 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161921: SwiftNINJA Microcatheter, Merit Medical Systems, Inc. (2016) Summary page 4.

## Most influential descendants
- K200582: Bendit2.7 Steerable Microcatheter (2020), 1 descendant of its own
- K211110: Agile Devices Angler Steerable, Deflectable Microcatheter (2022), 0 descendants of its own

## Indications for use
The Bendit2.7 Steerable Microcatheter is intended for general intravascular use in the peripheral vasculature. The microcatheter can be used for the delivery of diagnostic, embolic, or therapeutic materials into the vasculature. The Bendit2.7 is not intended to be used in intracranial or coronary vessels.

Source page: https://510kreport.com/device/K190126
Methodology: https://510kreport.com/methodology