K203193 is an FDA 510(k) clearance for the BD Intraosseous Infusion System. This device is classified as a Needle, Interosseous (Class II - Special Controls, product code MHC).
Submitted by Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] (Salt Lake Ciy,, US). The FDA issued a Cleared decision on March 4, 2021, 127 days after receiving the submission on October 28, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K203193 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2020 |
| Decision Date | March 04, 2021 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MHC - Needle, Interosseous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |