AZUR CX Detachable 35 Coils— 510(k) K151358
Substantially EquivalentMicroVention, Inc.
FDA 510(k) clearance K151358 for AZUR CX Detachable 35 Coils, Substantially Equivalent on 2015-09-25. Applicant: MicroVention, Inc.. Device class: 2.
Clearance details
- Applicant
- MicroVention, Inc.
- Product code
- Code KRD
- Device class
- Class 2
- Regulation
- 21 CFR 870.3300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tistin, CA, US
Recent devices under product code KRD
view allMore clearances from MicroVention, Inc.
view all- K232542 — Wedge XL Delivery Catheter
- K230775 — SOFIA EX Intracranial Support Catheter
- K222694 — EmPro EPS (EP4514C-190, EP6514C-190); Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
- K222115 — ISAAC Neurovascular Navigation Catheter
- K223050 — AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)
Adverse events under product code KRD
product code KRD- Death
- 119
- Injury
- 1,869
- Malfunction
- 7,015
- Other
- 1
- Total
- 9,004
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K151358
K-number listed on FDA's recall record- Z-0187-2024 — AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
- Z-1223-2020 — 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, 45-450410, 45-450415, 45-450405, 45-450610, 45-450615, 45-450620, 45-450815, 45-450820, and MV-AZ52030HD, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
- Z-1224-2020 — 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 Medical Corporation, Somerset, NJ; Made in Costa Rica.
- Z-1225-2020 — 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, MV-AX50511CD, MV-AX50617CD, MV-AX50824CD, and MV-AX51019CD, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151358.
Data sourced from openFDA. This site is unofficial and independent of the FDA.