Arisure Closed System Drug Transfer Device (CSTD)— 510(k) K201422
Substantially EquivalentYukon Medical, LLC
FDA 510(k) clearance K201422 for Arisure Closed System Drug Transfer Device (CSTD), Substantially Equivalent on 2021-03-02. Applicant: Yukon Medical, LLC. Device class: 2.
Clearance details
- Applicant
- Yukon Medical, LLC
- Product code
- Code ONB
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
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More clearances from Yukon Medical, LLC
view allAdverse events under product code ONB
product code ONB- Malfunction
- 3,615
- Other
- 13
- Total
- 3,628
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.