Cure Catheter Closed System; Cure Dextra Closed System— 510(k) K230400
UnknownConvatec, Inc.
FDA 510(k) clearance K230400 for Cure Catheter Closed System; Cure Dextra Closed System, Unknown on 2023-11-08. Applicant: Convatec, Inc.. Device class: 2.
Clearance details
- Applicant
- Convatec, Inc.
- Product code
- Code EZD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Greensboro, NC, US
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Adverse events under product code EZD
product code EZD- Injury
- 864
- Malfunction
- 2,210
- Total
- 3,074
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.