MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS


definition

Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K000956
Device Name MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
Original Applicant
BOSTON SCIENTIFIC SCIMED, INC.
one scimed place
maple grove, 
MN 
55311

Original Contact melanie raska
Regulation Number 870.1200
Classification Product Code
DQO  
Date Received 03/24/2000
Decision Date 04/21/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls