AZUR Vascular Plug— 510(k) K191680
Substantially EquivalentMicroVention, Inc.
FDA 510(k) clearance K191680 for AZUR Vascular Plug, Substantially Equivalent on 2020-03-20. 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
- Aliso Viejo, 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.