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. Device class: 2.
Clearance details
- Applicant
- J & J Solutions, Inc. D/B/A/ Corvida Medical
- 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
- Eagan, MN, US
Recent devices under product code ONB
view all- K251722 — ProSeal Transfer Injector (421120, 421130, 421140)
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- K250059 — BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)
- K251411 — Chemfort Female Luer Lock Adaptor
- K251340 — ProSeal Bag Spike with Additive Port (423370ST, 423370)
More clearances from J & J Solutions, Inc. D/B/A/ Corvida Medical
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.