CARPEDIEM System— 510(k) DEN180055
UnknownBellco Srl (Now Part of Medtronic, Inc)
FDA 510(k) clearance DEN180055 for CARPEDIEM System, Unknown on 2020-04-29. Applicant: Bellco Srl (Now Part of Medtronic, Inc). Device class: 2.
Clearance details
- Applicant
- Bellco Srl (Now Part of Medtronic, Inc)
- Product code
- Code QIR
- Device class
- Class 2
- Regulation
- 21 CFR 876.5861
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Mirandola, IT
Adverse events under product code QIR
product code QIR- Death
- 3
- Total
- 3
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.