The following data is part of a premarket notification filed by Kalila Medical, Inc. with the FDA for Vado Bi-directional Steerable Sheath.
| Device ID | K162427 |
| 510k Number | K162427 |
| Device Name: | Vado Bi-Directional Steerable Sheath |
| Classification | Introducer, Catheter |
| Applicant | KALILA MEDICAL, INC. 745 CAMDEN AVE, SUITE A Campbell, CA 95008 -4146 |
| Contact | Carrie Neuberger |
| Correspondent | Carrie Neuberger KALILA MEDICAL, INC. 745 CAMDEN AVE, SUITE A Campbell, CA 95008 -4146 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-30 |
| Decision Date | 2017-01-27 |
| Summary: | summary |