# K222095: BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101

- Pathway: 510(k) (Traditional)
- Applicant: Thrombolex, Inc.
- Decided: Apr 20, 2023 after 276 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: 5 generations back to K140151 (2014). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211080: EkoSonic Endovascular Device, Boston Scientific (2021) Summary page 4.

## Most influential descendants
- K231653: BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter (2023), 0 descendants of its own

## Indications for use
The BASHIR™ Endovascular Catheter and BASHIR™ S-B Endovascular Catheter are mechanical thrombolysis catheters indicated for the: • Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries for treatment of pulmonary embolism. • 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/K222095
Methodology: https://510kreport.com/methodology