MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS— 510(k) K981365

Substantially Equivalent

Sherwood Medical Co.

FDA 510(k) clearance K981365 for MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS, Substantially Equivalent on 1998-11-25. Applicant: Sherwood Medical Co..

Clearance details

Applicant: Sherwood Medical Co.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 1998-04-15
Decision date: 1998-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

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Adverse events under product code MSD

product code MSD

Death: 67
Injury: 545
Malfunction: 3,661
Total: 4,273

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.