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 | K200582 |
| 510k Number | K200582 |
| Device Name: | Bendit2.7 Steerable Microcatheter |
| Classification | Catheter, Continuous Flush |
| Applicant | Bend It Technologies Ltd. 25 Basel Street Petach Tikva, IL 4951038 |
| Contact | Simona Beilin-nissan |
| Correspondent | Sheila Hemeon-heyer Heyer Regulatory Solutions LLC P.O. Box 2151 Amherst, MA 01004 -2151 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-06 |
| Decision Date | 2020-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290018072001 | K200582 | 000 |