DeviceClearance

Product code PZW— General Hospital

3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large

Classification name
Catheter Access Cover, Tamper-Resistant
Device class
Class 2
Regulation
21 CFR 880.5970
Advisory panel
General Hospital
Total cleared
2
First cleared
Most recent

FDA classification definition

“A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter”

— U.S. Food and Drug Administration, device classification record for product code PZW under 21 CFR 880.5970, via openFDA

Market context for product code PZW

FDA has cleared 2 devices under product code PZW between 2020 and 2022, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PZW

Recent clearances under product code PZW

Data sourced from openFDA. This site is unofficial and independent of the FDA.