510(k) K180574
K180574 is an FDA 510(k) premarket notification submitted by J & J Solutions, Inc. D/B/A/ Corvida Medical for the device "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". The FDA issued a decision of Substantially Equivalent on Aug 17, 2018. The device falls under product code ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System), a Class II device regulated under 21 CFR 880.5440. J & J Solutions, Inc. D/B/A/ Corvida Medical has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 17, 2018
- Date Received
- Mar 5, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
- 510(k)
Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.