The following data is part of a premarket notification filed by Thrombolex, Inc. with the FDA for Bashir Plus Endovascular Catheter.
| Device ID | K193071 |
| 510k Number | K193071 |
| Device Name: | Bashir Plus Endovascular Catheter |
| 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 | 2019-11-04 |
| Decision Date | 2019-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850005115069 | K193071 | 000 |
| 00850005115052 | K193071 | 000 |
| 00850005115045 | K193071 | 000 |
| 00850005115038 | K193071 | 000 |