BD Intraosseous Infusion System— 510(k) K203193
Substantially EquivalentBard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]
FDA 510(k) clearance K203193 for BD Intraosseous Infusion System, Substantially Equivalent on 2021-03-04. Applicant: Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]. Device class: 2.
Clearance details
- Applicant
- Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]
- Product code
- Code MHC
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake Ciy,, UT, US
Recent devices under product code MHC
view allRecalls naming K203193
K-number listed on FDA's recall record- Z-2872-2026 — BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver 35mm x 15Ga, REF: D015351NK, BD Needle Kit for Powered Driver 45mm x 15Ga, REF: D015451NK, BD Needle Kit for Powered Driver 55mm x 15Ga, REF: D015551NK
- Z-1397-2022 — Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/ BD Manual Driver Needle Kit 15mm x 15Ga, D015251NK/ BD Needle Kit for Powered Driver 25mm x 15Ga, D015251MK/ BD Manual Driver Needle Kit 25mm x 15Ga, D015351NK/ BD Needle Kit for Powered Driver 35mm x 15Ga, D015351MK/ BD Manual Driver Needle Kit 35mm x 15Ga, D015451NK/ BD Needle Kit for Powered Driver 45mm x 15Ga, D015451MK/ BD Manual Driver Needle Kit 45mm x 15Ga, D015551NK/ BD Needle Kit for Powered Driver 55mm x 15Ga, D015551MK/ BD Manual Driver Needle Kit 55mm x 15G, D001001/ BD Intraosseous Powered Driver (drill)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203193.
Data sourced from openFDA. This site is unofficial and independent of the FDA.