6F & 7F INTRODUCING CATHETERS (MODIFICATION)


Device Classification Name

introducer, catheter

510(k) Number K001135
Device Name 6F & 7F INTRODUCING CATHETERS (MODIFICATION)
Original Applicant
CORDIS CORP.
14201 n.w. 60th ave.
miami lakes, 
FL 
33014

Original Contact dennis s griffin
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 04/10/2000
Decision Date 07/03/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No