The following data is part of a premarket notification filed by Thrombolex, Inc. with the FDA for 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).
| Device ID | K211061 |
| 510k Number | K211061 |
| Device Name: | 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) |
| Classification | Catheter, Continuous Flush |
| Applicant | Thrombolex, Inc. 75 New Britain Dr. New Britain, PA 18901 |
| Contact | Amy Katsikis |
| Correspondent | Diane Horwitz Eminence Clinical Research Inc. 5 Lake Como Ct. Greenville, SC 29609 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-09 |
| Decision Date | 2021-06-10 |