CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT


Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K024126
Device Name CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
Original Applicant
ABBOTT LABORATORIES
200 abbott park rd.
d-389, bldg j-45
abbott park, 
IL 
60064 -3500

Original Contact nicohl r wilding
Regulation Number 870.1200
Classification Product Code
DQO  
Date Received 12/16/2002
Decision Date 01/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No