510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191195Substantially Equivalent

PiccGuard

Piccguard, LLC, Beloit WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191195 is the FDA 510(k) clearance record for PiccGuard, a class II device, cleared for Piccguard, LLC on under FDA product code PZW (Catheter Access Cover, Tamper-Resistant). FDA's definition for product code PZW reads: "A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter". FDA records list one 510(k) clearance for Piccguard, LLC. As of , FDA records show no recalls naming K191195.

Clearance record

Decision date
Received
(245 days to decision)
Product code
PZW Catheter Access Cover, Tamper-Resistant
Regulation
21 CFR 880.5970
Device class
Class II
Review panel
General Hospital
Applicant
Piccguard, LLC 2677 Sarah Ln., Beloit WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PZW

Trailing 12 months

FDA records hold no clearances under product code PZW in the trailing twelve months.

FDA records show no clearances under product code PZW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PZW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260