Thoraguard System— 510(k) K181667
Substantially EquivalentCentese, Inc.
FDA 510(k) clearance K181667 for Thoraguard System, Substantially Equivalent on 2018-11-29. Applicant: Centese, Inc..
Clearance details
- Applicant
- Centese, Inc.
- Product code
- Code BTA
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Omaha, NE, US
Adverse events under product code BTA
product code BTA- Death
- 5
- Total
- 5
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.