TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP— 510(k) K844340

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K844340 for TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP, Substantially Equivalent on 1985-01-09. Applicant: Travenol Laboratories, S.A..

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 1984-11-08
Decision date: 1985-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield, IL, US

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Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.