# K193071: Bashir Plus Endovascular Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Thrombolex, Inc.
- Decided: Dec 17, 2019 after 43 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K904788 (1990). 50 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183290: Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200, Thrombolex, Inc. (2019) Summary page 5.

## Most influential descendants
- K211061: BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240) (2021), 0 descendants of its own

## Indications for use
The Bashir™ Plus Endovascular Catheters are intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Source page: https://510kreport.com/device/K193071
Methodology: https://510kreport.com/methodology