NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER— 510(k) K113227

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K113227 for NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER, Substantially Equivalent on 2011-12-08. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code FPB
Advisory panel: General Hospital
Date received: 2011-11-01
Decision date: 2011-12-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Deerfield, IL, US

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Adverse events under product code FPB

product code FPB

Other: 1
Total: 1

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.