510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821577Substantially Equivalent

Deseret Angio Guide

Warner-Lambert Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821577 is the FDA 510(k) clearance record for DESERET ANGIO GUIDE, a class II device, cleared for Warner-Lambert Co. on under FDA product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days). FDA records list 50 510(k) clearances for Warner-Lambert Co., from to . As of , FDA records show no recalls naming K821577.

Clearance record

Decision date
Received
(19 days to decision)
Product code
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Warner-Lambert Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FOZ

Trailing 12 months
9 clearances under product code FOZ in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FOZ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20262
May 20261
June 20260
July 20262
August 20261
September 20261
October 20260