BD Intraosseous Vascular Access System EMS Powered Driver (D001003)
FDA 510(k) clearance K223198 · decided 2022-11-10
Clearance details
- K-number
- K223198
- Device name
- BD Intraosseous Vascular Access System EMS Powered Driver (D001003)
- Applicant
- Bard Access Systems
- Decision
- Substantially Equivalent
- Date received
- 2022-10-13
- Decision date
- 2022-11-10
- Days to decision
- 28 days
- Clearance type
- Special
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BD Intraosseous Infusion System (K203193) | Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] | 2021-03-04 |
Recalls involving this device
No recalls on record reference this clearance.