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 Piccguard, LLC and 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
Cleared
May 23, 2022
3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large
3M Company
General Hospital
90d
Cleared
Jan 03, 2020
PiccGuard
Piccguard, LLC
General Hospital
245d
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.