510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030524Substantially Equivalent

Cd Leycom 7 Fr Pressure/volume Catheter (10 Mm Electrode Spacing) Pressure/volume Combination Catheter with Lumen

CD Leycom, Zoetermeer, NL / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K030524 is the FDA 510(k) clearance record for CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN, a class II device, cleared for Cd Leycom BV on under FDA product code OBJ (Catheter, Ultrasound, Intravascular). FDA's definition for product code OBJ reads: "For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology". FDA records list 3 510(k) clearances for Cd Leycom BV, from to . As of , FDA records show no recalls naming K030524.

Clearance record

Decision date
Received
(12 days to decision)
Product code
OBJ Catheter, Ultrasound, Intravascular
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Cd Leycom BV Argonstraat 116, Zoetermeer, NL
510(k) summary
Statement
Third party review
No

Clearances, product code OBJ

Trailing 12 months
4 clearances under product code OBJ 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 OBJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260