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.. Device class: 2.
Clearance details
- Applicant
- Centese, Inc.
- Product code
- Code BTA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Omaha, NE, US
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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.