510(k) K132928— MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE

Substantially Equivalent

Medrad, Inc. / Bayer Medical Care, Inc.

Clearance details

Applicant: Medrad, Inc. / Bayer Medical Care, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2013-09-18
Decision date: 2014-01-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianola, PA, US

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.