INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM— 510(k) K002380

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K002380 for INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM, Substantially Equivalent on 2000-09-05. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code FRN
Advisory panel: General Hospital
Date received: 2000-08-04
Decision date: 2000-09-05
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.