# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Thrombolex, Inc.
- Decided: Jun 10, 2021 after 62 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: 20 generations back to K904788 (1990). 51 ancestors in all.
No later device cites it as a predicate yet.
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.
- K193071: Bashir Plus Endovascular Catheter, Thrombolex, Inc. (2019) Summary page 5.

## Indications for use
The BASHIR™ Endovascular Catheter and the BASHIR™ Plus Endovascular Catheters (BASHIR™+ 10, BASHIR™+20, BASHIR™+30, BASHIR™+40) are intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.

Source page: https://510kreport.com/device/K211061
Methodology: https://510kreport.com/methodology