VIRAPUMP II (MODELS AND MODEL M)— 510(k) K961607

Substantially Equivalent

Viatro, Corp.

FDA 510(k) clearance K961607 for VIRAPUMP II (MODELS AND MODEL M), Substantially Equivalent on 1996-12-06. Applicant: Viatro, Corp..

Clearance details

Applicant: Viatro, Corp.
Product code: Code FEB
Advisory panel: Gastroenterology, Urology
Date received: 1996-04-25
Decision date: 1996-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

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Adverse events under product code FEB

product code FEB

Malfunction: 3,879
Total: 3,879

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.