WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S— 510(k) K102022

Substantially Equivalent

Avinger, Inc.

FDA 510(k) clearance K102022 for WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S, Substantially Equivalent on 2010-08-06. Applicant: Avinger, Inc..

Clearance details

Applicant: Avinger, Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2010-07-19
Decision date: 2010-08-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood City, CA, US

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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.