510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253842Substantially Equivalent

Vena MicroAngioscope™ System

Vena Medical Holdings Corp., Kitchener, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253842 is the FDA 510(k) clearance record for Vena MicroAngioscope™ System, a class II device, cleared for Vena Medical Holdings Corp on under FDA product code LYK (Angioscope). FDA records list 2 510(k) clearances for Vena Medical Holdings Corp, from to . As of , FDA records show no recalls naming K253842.

Clearance record

Decision date
Received
(57 days to decision)
Product code
LYK Angioscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Vena Medical Holdings Corp 809 Wellington St., Kitchener, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LYK

Trailing 12 months
1 clearance under product code LYK in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LYK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260