Artix Ballon Guiding Sheath— 510(k) K221846

Substantially Equivalent

Inari Medical

FDA 510(k) clearance K221846 for Artix Ballon Guiding Sheath, Substantially Equivalent on 2022-07-11. Applicant: Inari Medical.

Clearance details

Applicant: Inari Medical
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2022-06-24
Decision date: 2022-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.