SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS— 510(k) K904223

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K904223 for SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS, Substantially Equivalent on 1990-10-26. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code CAK
Advisory panel: General Hospital
Date received: 1990-09-13
Decision date: 1990-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

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Adverse events under product code CAK

product code CAK

Malfunction: 476
Total: 476

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.