INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES— 510(k) K062457

Substantially Equivalent

Baxter Healthcare Corporation

FDA 510(k) clearance K062457 for INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES, Substantially Equivalent on 2006-09-21. Applicant: Baxter Healthcare Corporation.

Clearance details

Applicant: Baxter Healthcare Corporation
Product code: Code MEB
Advisory panel: General Hospital
Date received: 2006-08-23
Decision date: 2006-09-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Mcgaw Park, IL, US

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Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

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.