Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor— 510(k) K180574
Substantially EquivalentJ & J Solutions, Inc. D/B/A/ Corvida Medical
FDA 510(k) clearance K180574 for Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor, Substantially Equivalent on 2018-08-17. Applicant: J & J Solutions, Inc. D/B/A/ Corvida Medical.
Clearance details
- Applicant
- J & J Solutions, Inc. D/B/A/ Corvida Medical
- Product code
- Code ONB
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eagan, MN, US
Adverse 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.