510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050808Substantially Equivalent

Coronary Sinus Access Kit, Model Kcs8f-01

Cardio-Optics, Inc., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050808 is the FDA 510(k) clearance record for CORONARY SINUS ACCESS KIT, MODEL KCS8F-01, a class II device, cleared for Cardio-Optics, Inc. on under FDA product code LYK (Angioscope). FDA records list 2 510(k) clearances for Cardio-Optics, Inc., from to . As of , FDA records show no recalls naming K050808.

Clearance record

Decision date
Received
(120 days to decision)
Product code
LYK Angioscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cardio-Optics, Inc. 2477 55th St., Suite 120, Boulder CO
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