K230400
- 510(k) number
- K230400
- Device name
- Cure Catheter Closed System; Cure Dextra Closed System
- Applicant
- Convatec, Inc. NC · US
- Product code
- EZD — Catheter, Straight
- Decision date
- 2023-11-08
- Date received
- 2023-02-15
- Decision
- Unknown
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K230400.pdf
Official FDA record: K230400
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.