WavelinQ 4F EndoAVF System— 510(k) K182796

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K182796 for WavelinQ 4F EndoAVF System, Substantially Equivalent on 2019-02-06. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code PQK
Advisory panel: Cardiovascular
Date received: 2018-10-01
Decision date: 2019-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

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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.