CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN


Device Classification Name

catheter, ultrasound, intravascular

510(k) Number K030524
Device Name CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN
Applicant
CD LEYCOM BV
argonstraat 116
zoetermeer, 

NL

2718 sp

Applicant Contact t. lopes
Correspondent
CD LEYCOM BV
argonstraat 116
zoetermeer, 

NL

2718 sp

Correspodent Contact t. lopes
Regulation Number 870.1200
Classification Product Code
OBJ  
Date Received 02/19/2003
Decision Date 03/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No