AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35— 510(k) K122543
Substantially EquivalentMicroVention, Inc.
FDA 510(k) clearance K122543 for AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35, Substantially Equivalent on 2012-11-28. 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.