510(k) K901337 ยท HCG Device, Neurovascular Embolization
HILAL EMBOLIZATION MICROCOIL(TM)
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Nov 13, 1990 |
| Received | Mar 22, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901337
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | Cook, Inc. Cook Hilal Embolization Microcoil, 3 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations. Terminated |
HCG | None listed |
| Sep 16, 2008 | Cook, Inc. Cook Hilal Embolization Microcoil, 6 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations. Terminated |
HCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.