510(k) K103825 ยท LZG Pump, Infusion, Insulin
V-GO INSULIN DELIVERY SYSTEM
| Applicant | Valeritas, Inc., Shrewsbury MA, US |
| Decision | Substantially Equivalent, Feb 23, 2011 |
| Received | Dec 30, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103825
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2019 | Valeritas, Incorporated DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03 Terminated |
LZG | None listed |
| Jul 3, 2019 | Valeritas, Incorporated DEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02 Terminated |
LZG | None listed |
| Jul 3, 2019 | Valeritas, Incorporated DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01 Terminated |
LZG | None listed |
| Jul 3, 2019 | Valeritas, Incorporated DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03 Terminated |
LZG | None listed |
| Jul 3, 2019 | Valeritas, Incorporated DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02 Terminated |
LZG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.