510(k) K151358 ยท KRD Device, Vascular, For Promoting Embolization
AZUR CX Detachable 35 Coils
| Applicant | MicroVention, Inc., Tistin CA, US |
| Decision | Substantially Equivalent, Sep 25, 2015 |
| Received | May 20, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151358
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2023 | MICROVENTION INC. AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324 Open, Classified |
KRD | None listed |
| Nov 24, 2019 | Microvention, Inc. Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030 Terminated |
KRD | None listed |
| Nov 24, 2019 | Microvention, Inc. Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Terminated |
KRD | None listed |
| Nov 24, 2019 | Microvention, Inc. Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039, 45-750407, 45-750511, 45-750617, 45-750609, 45-750812, 45-750824, MV-AX50407CD, M Terminated |
KRD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.