K012225

Substantially Equivalent

ATTAIN 6215 VENOGRAM BALLOON CATHETER

Applicant: Medtronic Vascular
Product code: DYG
Advisory panel: Cardiovascular
Date received: 2001-07-16
Decision date: 2001-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

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.