Wingman 14, Wingman 14C, Wingman 18, Wingman 35— 510(k) K193596

Substantially Equivalent

Reflow Medical

FDA 510(k) clearance K193596 for Wingman 14, Wingman 14C, Wingman 18, Wingman 35, Substantially Equivalent on 2020-02-20. Applicant: Reflow Medical.

Clearance details

Applicant: Reflow Medical
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2019-12-23
Decision date: 2020-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, 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.