510(k) K153658 ยท HCG Device, Neurovascular Embolization
Target Detachable Coils
| Applicant | Stryker Neurovascular, Fremont CA, US |
| Decision | Substantially Equivalent, May 19, 2016 |
| Received | Dec 21, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153658
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET 360 NANO 1 MM X 2 CM
MODEL Number: M0035421020
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormaliti Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET 360 NANO 1 MM X 3 CM
MODEL Number: M0035421030
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormaliti Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET 360 NANO 1.5 MM X 2 CM
MODEL Number: M0035421520
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormali Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET 360 NANO 1.5 MM X 3 CM
MODEL Number: M0035421530
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormali Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET 360 NANO 1.5 MM X 4 CM
MODEL Number:M0035421540
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalit Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET HELICAL NANO 1 MM X 1 CM
MODEL Number:M0035431010
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormal Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET HELICAL NANO 1 MM X 2 CM
MODEL Number:M0035431020
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnorma Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET HELICAL NANO 1 MM X 3 CM
MODEL Number:M0035431030
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnorm Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET HELICAL NANO 1.5 MM X 1 CM
MODEL Number:M0035431510
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnorm Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET HELICAL NANO 1.5 MM X 2 CM
MODEL Number:M0035431520
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnor Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET HELICAL NANO 1.5 MM X 3 CM
MODEL Number:M0035431530
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnor Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET HELICAL NANO 1.5 MM X 4 CM
MODEL Number:M0035431540
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnorm Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET 360 NANO 2MM X 3CM
MODEL Number:M0035442030
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET 360 NANO 2MM X 4CM
MODEL Number:M0035442040
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET 360 NANO 2.5 MM X 4CM
MODEL Number:M0035442540
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalit Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET 360 NANO 3MM X 4CM
MODEL Number:M0035443040
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET 360 NANO 3MM X 6CM
MODEL Number:M0035443060
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET 360 NANO 3.5 MM X 6CM
MODEL Number:M0035443560
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalit Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET HELICAL NANO 2MM X 2CM
MODEL Number:M0035452020
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormal Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET HELICAL NANO 2MM X 3CM
MODEL Number:M0035452030
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnorma Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET HELICAL NANO 2MM X 4CM
MODEL Number:M0035452040
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnor Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET HELICAL NANO 2MM X 6CM
MODEL Number:M0035452060
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnorm Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET HELICAL NANO 2.5MM X 3CM
MODEL Number:M0035452530
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnorma Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET HELICAL NANO 2.5MM X 4CM
MODEL Number:M0035452540
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnorma Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET HELICAL NANO 3MM X 4CM
MODEL Number:M0035452560
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalit Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET HELICAL NANO 3MM X 4CM
MODEL Number:M0035453040
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormali Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET HELICAL NANO 3MM X 6CM
MODEL Number:M0035453060
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormali Terminated |
HCG | None listed |
| Jul 11, 2016 | Stryker Neurovascular Target Detachable Coils:
TARGET HELICAL NANO 3MM X 8CM
MODEL Number:M0035453080
Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormali Terminated |
HCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.