PZW · Class II · 21 CFR 880.5970

FDA Product Code PZW: Catheter Access Cover, Tamper-resistant

A Tamper Resistant Catheter Access Cover Is Intended To Control Unauthorized Access To A Central Venous Catheter

Leading manufacturers include 3M Company.

2
Total
2
Cleared
168d
Avg days
2020
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Catheter Access Cover, Tamper-resistant Devices (Product Code PZW)

2 devices
1–2 of 2

About Product Code PZW - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code PZW since 2020, with 2 receiving FDA clearance (average review time: 168 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

PZW devices are reviewed by the General Hospital panel. Browse all General Hospital devices →