STRATOFUSE PCA II INFUSER— 510(k) K941151

Substantially Equivalent

Infusion Technology Intl.

FDA 510(k) clearance K941151 for STRATOFUSE PCA II INFUSER, Substantially Equivalent on 1994-07-07. Applicant: Infusion Technology Intl..

Clearance details

Applicant: Infusion Technology Intl.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 1994-03-11
Decision date: 1994-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

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Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.