ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA— 510(k) K882680

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K882680 for ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA, Substantially Equivalent on 1988-07-22. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code FJI
Advisory panel: Gastroenterology, Urology
Date received: 1988-06-29
Decision date: 1988-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

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Adverse events under product code FJI

product code FJI

Death: 2
Total: 2

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.