Intraosseous Cannula System Bio-MAC¿ and Bio-CORE
FDA 510(k) clearance K141910 · decided 2015-05-04
Clearance details
- K-number
- K141910
- Device name
- Intraosseous Cannula System Bio-MAC¿ and Bio-CORE
- Applicant
- Biologic Therapies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-15
- Decision date
- 2015-05-04
- Days to decision
- 293 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Prior Lake, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bio-MAC Cannula (Needle) Set recall (Z-1373-2015) | Biologic Therapies, Inc | 2015-04-02 |
| Bio-CORE Cannula (Needle) Set recall (Z-1374-2015) | Biologic Therapies, Inc | 2015-04-02 |