510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182149Substantially Equivalent

FFRangio System

Cathworks Ltd., Kfar-Saba, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182149 is the FDA 510(k) clearance record for FFRangio System, a class II device, cleared for Cathworks, Ltd. on under FDA product code QEK (Angiographic Coronary Vascular Physiologic Simulation Software). FDA's definition for product code QEK reads: "An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease". FDA records list 2 510(k) clearances for Cathworks, Ltd., from to . As of , FDA records show no recalls naming K182149.

Clearance record

Decision date
Received
(133 days to decision)
Product code
QEK Angiographic Coronary Vascular Physiologic Simulation Software
Regulation
21 CFR 870.1415
Device class
Class II
Review panel
Cardiovascular
Applicant
Cathworks, Ltd. 3 Rapaport St., Kfar-Saba, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QEK

Trailing 12 months

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

FDA records show no clearances under product code QEK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QEK, 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