BD Intraosseous Infusion System
FDA 510(k) clearance K203193 · decided 2021-03-04
Clearance details
- K-number
- K203193
- Device name
- BD Intraosseous Infusion System
- Applicant
- Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]
- Decision
- Substantially Equivalent
- Date received
- 2020-10-28
- Decision date
- 2021-03-04
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- MHC
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Salt Lake Ciy,, UT, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| BD Intraosseous Vascular Access System EMS Powered Driver (D001003) (K223198) | Bard Access Systems | 2022-11-10 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Dr recall (Z-2872-2026) | Bard Access Systems, Inc. | 2026-08-14 |
| Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered D recall (Z-1397-2022) | Bard Access Systems, Inc. | 2022-07-22 |