ATTAIN 6215 VENOGRAM BALLOON CATHETER— 510(k) K012225

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K012225 for ATTAIN 6215 VENOGRAM BALLOON CATHETER, Substantially Equivalent on 2001-08-28. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: 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

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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.