Catheter Access Cover, Tamper-Resistant
The Catheter Access Cover, Tamper-Resistant is a device intended to control unauthorized access to a central venous catheter, providing a physical security mechanism to prevent tampering and potential contamination or unauthorized fluid administration. It is classified as a Class 2 device under regulation 880.5970, requiring 510(k) premarket notification, and falls within the General Hospital (HO) medical specialty. The product code is PZW. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PZW
- Device Class
- FDA class 2
- Regulation Number
- 880.5970
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.