SAFESITE INJECTION SITE AND BLUNT CANNULA— 510(k) K883638

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K883638 for SAFESITE INJECTION SITE AND BLUNT CANNULA, Substantially Equivalent on 1988-09-23. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1988-08-25
Decision date: 1988-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.