The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Ultraclip Ii Us Wing And Coil, Models: 862017u, 864017u.
| Device ID | K090547 |
| 510k Number | K090547 |
| Device Name: | ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U |
| Classification | Marker, Radiographic, Implantable |
| Applicant | C.R. BARD, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 -2438 |
| Contact | Cindy Moss |
| Correspondent | Cindy Moss C.R. BARD, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 -2438 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-02 |
| Decision Date | 2009-03-18 |
| Summary: | summary |