# K192598: Bashir S-B Endovascular Catheter, Ref. No. 7101

- Pathway: 510(k) (Special)
- Applicant: Thrombolex, Inc.
- Decided: Oct 18, 2019 after 28 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.
No later device cites it as a predicate yet.
0 of 51 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.

## Indications for use
The Bashir™ S-B Endovascular Catheter is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Source page: https://510kreport.com/device/K192598
Methodology: https://510kreport.com/methodology