The following data is part of a premarket notification filed by Bend It Technologies Ltd with the FDA for Bendit21 Microcatheter.
| Device ID | K203842 |
| 510k Number | K203842 |
| Device Name: | Bendit21 Microcatheter |
| Classification | Catheter, Percutaneous, Neurovasculature |
| Applicant | Bend It Technologies Ltd 25 Basel Street Petach Tikva, IL 4951038 |
| Contact | Simona Beilin-nissan |
| Correspondent | Sheila Hemeon-heyer Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002 |
| Product Code | QJP |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-31 |
| Decision Date | 2022-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290018072049 | K203842 | 000 |