MOD TARGET/TIPS # 4011,4012,4511,4512,6912,4016— 510(k) K854582

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K854582 for MOD TARGET/TIPS # 4011,4012,4511,4512,6912,4016, Substantially Equivalent on 1986-01-13. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code DTB
Advisory panel: Cardiovascular
Date received: 1985-11-15
Decision date: 1986-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTB

product code DTB

Death: 1,491
Injury: 67,311
Malfunction: 79,368
Other: 10
Total: 148,180

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.