ADDITIVE CAP— 510(k) K111217

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K111217 for ADDITIVE CAP, Substantially Equivalent on 2011-06-14. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code KPE
Advisory panel: General Hospital
Date received: 2011-05-02
Decision date: 2011-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, US

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Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.