510(k) K150486 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Halo
| Applicant | J & J Solutions, Inc. D/B/A/ Corvida Medical, Coralville IA, US |
| Decision | Substantially Equivalent, Jul 24, 2015 |
| Received | Feb 24, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150486
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 22, 2016 | J&J Solutions, Inc. DBA Corvida Medical Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped 60 units/box and 4 boxes/shipping carton Corvida Medical, Cor Terminated |
ONB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.