The following data is part of a premarket notification filed by Bend It Technologies Ltd with the FDA for Bendit2.7 Steerable Microcatheter.
| Device ID | K190126 |
| 510k Number | K190126 |
| Device Name: | Bendit2.7 Steerable Microcatheter |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | Bend It Technologies Ltd 25 Basel Street Petach Tikva, IL 4951038 |
| Contact | Nitza Shoham |
| Correspondent | Sheila Hemeon-heyer Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-28 |
| Decision Date | 2019-08-22 |