SHADOW-CATHS— 510(k) K780643

Substantially Equivalent

Quinton, Inc.

FDA 510(k) clearance K780643 for SHADOW-CATHS, Substantially Equivalent on 1978-04-27. Applicant: Quinton, Inc..

Clearance details

Applicant: Quinton, Inc.
Product code: Code FJS
Advisory panel: Gastroenterology, Urology
Date received: 1978-04-17
Decision date: 1978-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FJS

product code FJS

Death: 34
Injury: 652
Malfunction: 576
Other: 6
Total: 1,268

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.