510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PZWClass II

Catheter Access Cover, Tamper-Resistant

21 CFR 880.5970 / General Hospital
FDA source (opens on fda.gov)

PZW is the FDA product code for Catheter Access Cover, Tamper-Resistant, a class II device type, regulated under 21 CFR 880.5970. FDA's definition for this code reads: "A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PZW
Device name
Catheter Access Cover, Tamper-Resistant
FDA definition
A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter
Regulation
21 CFR 880.5970
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code PZW

By decision year
2 clearances under product code PZW with a decision year between 2020 and 2022, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PZW by decision year
YearClearances
20201
20221

Applicants with the most clearances

Product code PZW
Applicants holding the most 510(k) clearances under product code PZW
ApplicantClearances
3M Company1
Piccguard, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code