CATHETERS, BILIARY CATHETERS, UROLOGICAL— 510(k) K944290

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K944290 for CATHETERS, BILIARY CATHETERS, UROLOGICAL, Substantially Equivalent on 1994-12-08. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code FFA
Advisory panel: Gastroenterology, Urology
Date received: 1994-09-02
Decision date: 1994-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

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Adverse events under product code FFA

product code FFA

Death: 3
Total: 3

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.