The following data is part of a premarket notification filed by Thrombolex, Inc. with the FDA for Bashir Endovascular Catheter Model 7201, Bashir N-x Endovascular Catheter, Mode 7200.
| Device ID | K183290 |
| 510k Number | K183290 |
| Device Name: | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 |
| Classification | Catheter, Continuous Flush |
| Applicant | Thrombolex, Inc. 51 Britain Dr. New Britain, PA 18901 |
| Contact | Amy Katsikis |
| Correspondent | Diane Horwitz Eminence Clinical Research Inc. 2995 Steven Martin Dr. Fairfax, VA 22031 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-26 |
| Decision Date | 2019-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850005115014 | K183290 | 000 |
| 00850005115007 | K183290 | 000 |