Tri-Ad 2.0 Adams Tricuspid Band— 510(k) K181132

Substantially Equivalent

Medtronic

FDA 510(k) clearance K181132 for Tri-Ad 2.0 Adams Tricuspid Band, Substantially Equivalent on 2018-05-29. Applicant: Medtronic.

Clearance details

Applicant: Medtronic
Product code: Code KRH
Advisory panel: Cardiovascular
Date received: 2018-04-30
Decision date: 2018-05-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRH

product code KRH

Death: 45
Injury: 2,235
Total: 2,280

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.