510(k) K171862 ยท HCG Device, Neurovascular Embolization
GALAXY G3 Mini Microcoil Delivery System
| Applicant | Codman & Shurtleff, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Sep 25, 2017 |
| Received | Jun 22, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171862
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2019 | Codman & Shurtleff Inc GALAXY G3 Mini Microcoil Delivery System
Product No: GLM915030 (3 cm). Terminated |
HCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.