# K231653: BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter

- Pathway: 510(k) (Special)
- Applicant: Thrombolex, Inc.
- Decided: Jul 3, 2023 after 27 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: 6 generations back to K140151 (2014). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222095: BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101, Thrombolex, Inc. (2023) Summary page 4.

## Indications for use
The BASHIR™ .035 Endovascular Catheter and BASHIR™ S-B .035 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/K231653
Methodology: https://510kreport.com/methodology