The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Denali Filter System- Femoral Delivery Kit And Jugular Delivery Kit.
| Device ID | K130366 |
| 510k Number | K130366 |
| Device Name: | BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | C.R. BARD, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 |
| Contact | Joni Creal |
| Correspondent | Joni Creal C.R. BARD, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-13 |
| Decision Date | 2013-05-15 |
| Summary: | summary |