FLO-GARD(R) 6301— 510(k) K915523

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K915523 for FLO-GARD(R) 6301, Substantially Equivalent on 1992-02-28. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code FRN
Advisory panel: General Hospital
Date received: 1991-12-10
Decision date: 1992-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

Download summary PDF View on FDA.gov ↗

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.