MODEL 611101 CONTRAST INJECTION DEVICE— 510(k) K890898

Substantially Equivalent

Medtronic Versaflex, Inc.

FDA 510(k) clearance K890898 for MODEL 611101 CONTRAST INJECTION DEVICE, Substantially Equivalent on 1989-04-12. Applicant: Medtronic Versaflex, Inc..

Clearance details

Applicant: Medtronic Versaflex, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1989-02-22
Decision date: 1989-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.