The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Ultracor Twirl Breast Tissue Marker.
| Device ID | K152510 |
| 510k Number | K152510 |
| Device Name: | UltraCor Twirl Breast Tissue Marker |
| Classification | Marker, Radiographic, Implantable |
| Applicant | BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD STREET Tempe, AZ 85281 |
| Contact | Kristen Dejeu |
| Correspondent | Kristen Dejeu BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD STREET Tempe, AZ 85281 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-02 |
| Decision Date | 2016-05-13 |
| Summary: | summary |