Tri-Ad 2.0 Adams Tricuspid Band— 510(k) K181132
Substantially EquivalentMedtronic
FDA 510(k) clearance K181132 for Tri-Ad 2.0 Adams Tricuspid Band, Substantially Equivalent on 2018-05-29. Applicant: Medtronic. Device class: 2.
Clearance details
- Applicant
- Medtronic
- Product code
- Code KRH
- Device class
- Class 2
- Regulation
- 21 CFR 870.3800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Santa Ana, CA, US
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Adverse events under product code KRH
product code KRH- Death
- 45
- Injury
- 2,235
- Total
- 2,280
Source: openFDA MAUDE database, through . 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.