AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35— 510(k) K122543

Substantially Equivalent

MicroVention, 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..

Clearance details

Applicant: MicroVention, Inc.
Product code: Code KRD
Advisory panel: Cardiovascular
Date received: 2012-08-21
Decision date: 2012-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tistin, CA, US

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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, 2020-01-01 through 2026-04-23. 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.