CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER


information about

Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K003020
Device Name CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER
Original Applicant
CD LEYCOM BV
argonstraat 116
zoetermeer, 

NL

2718 sp

Original Contact tim lenihan
Regulation Number 870.1200
Classification Product Code
DQO  
Subsequent Product Codes
DRQ   DXO  
Date Received 09/27/2000
Decision Date 05/11/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No