# Thrombolex, Inc.

- Location (FDA's records): New Britain, PA
- FDA decisions: 6 (2019–2023): 6 510(k) clearances
- Product codes: QEY (6)
- 510(k) review time since 2016: median 53 days, against 91 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 7 (5 its own); citations of its devices by later devices: 7 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ekos Corp.: 1 (https://510kreport.com/company/ekos)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)

## Firms that cite its devices most
- Liquet Medical, Inc.: 1 (https://510kreport.com/company/liquet-medical)
- AngioDynamics, Inc.: 1 (https://510kreport.com/company/angiodynamics)

## Its most-cited devices
- K183290: Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 (2019), cited by 5
- K193071: Bashir Plus Endovascular Catheter (2019), cited by 1
- K222095: BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 (2023), cited by 1

## Recent decisions
- K231653: BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter (Jul 3, 2023)
- K222095: BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 (Apr 20, 2023)
- 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) (Jun 10, 2021)
- K193071: Bashir Plus Endovascular Catheter (Dec 17, 2019)
- K192598: Bashir S-B Endovascular Catheter, Ref. No. 7101 (Oct 18, 2019)
- K183290: Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 (Feb 25, 2019)

Source page: https://510kreport.com/company/thrombolex