MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE— 510(k) K934086

Substantially Equivalent

Medrad, Inc.

FDA 510(k) clearance K934086 for MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE, Substantially Equivalent on 1995-06-15. Applicant: Medrad, Inc..

Clearance details

Applicant: Medrad, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1993-08-24
Decision date: 1995-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.