MEDRAD Mark 7 Arterion Injection System— 510(k) K193028

Substantially Equivalent

Bayer Medical Care, Inc.

FDA 510(k) clearance K193028 for MEDRAD Mark 7 Arterion Injection System, Substantially Equivalent on 2019-12-05. Applicant: Bayer Medical Care, Inc..

Clearance details

Applicant: Bayer Medical Care, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2019-10-30
Decision date: 2019-12-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianaola, PA, US

Download summary PDF View on FDA.gov ↗

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.