The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/subclavian Delivery Kit.
| Device ID | K160866 |
| 510k Number | K160866 |
| Device Name: | Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | C.R. BARD, INC. 1625 W. THIRD ST. Tempe, AZ 85281 |
| Contact | Laurie Sang |
| Correspondent | Laurie Sang C.R. BARD, INC. 1625 W. THIRD ST. Tempe, AZ 85281 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-30 |
| Decision Date | 2016-04-29 |
| Summary: | summary |