PZW — Catheter Access Cover, Tamper-Resistant Class II
FDA product code PZW covers "Catheter Access Cover, Tamper-Resistant", a Class II medical device regulated under 21 CFR 880.5970. Submissions are reviewed by the General Hospital panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PZW
- Device Class
- Class II
- Regulation Number
- 880.5970
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter