3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000— 510(k) K980089

Substantially Equivalent

Valley West, Inc.

FDA 510(k) clearance K980089 for 3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000, Substantially Equivalent on 1998-03-24. Applicant: Valley West, Inc..

Clearance details

Applicant: Valley West, Inc.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 1998-01-09
Decision date: 1998-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Meridian, TX, 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.