K192239

Substantially Equivalent

WavelinQ Plus EndoAVF System

Applicant: C.R. Bard, Inc.
Product code: PQK
Advisory panel: Cardiovascular
Date received: 2019-08-19
Decision date: 2019-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Adverse events under product code PQK

product code PQK

Death: 7
Injury: 191
Total: 198

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.