BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD— 510(k) K902588

Substantially Equivalent

Gambro-Hospal, Inc.

FDA 510(k) clearance K902588 for BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD, Substantially Equivalent on 1991-03-07. Applicant: Gambro-Hospal, Inc..

Clearance details

Applicant: Gambro-Hospal, Inc.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1990-06-12
Decision date: 1991-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Williamsburg, VA, US

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Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.