510(k) K120630 ยท KRD Device, Vascular, For Promoting Embolization
AZUR DETACHABLE 18
| Applicant | MicroVention, Inc., Tistin CA, US |
| Decision | Substantially Equivalent, Mar 28, 2012 |
| Received | Mar 1, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120630
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 24, 2019 | Microvention, Inc. Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-481220, 45-481515, 45-481520, 45-482020, 45-482030, 45-480202, Terminated |
KRD | None listed |
| Nov 24, 2019 | Microvention, Inc. Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Terminated |
KRD | None listed |
| Nov 24, 2019 | Microvention, Inc. Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-780202, 45-780204, 45-780304, 45-780308, 45-780413, 45-7 Terminated |
KRD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.