POY
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Post Breast Biopsy Hemostatic Breast Compression Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1710
- Medical specialty
- Radiology
- FDA definition
- To achieve and maintain hemostasis of a breast biopsy wound site.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| XPress BCD Breast Compression Device (K163388) | Xpress Bcd, LLC | 2017-07-19 | + Add |
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Every clearance here is in the API, with alerts when new ones post.