4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER


definition

Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K000825
Device Name 4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER
Original Applicant
MEDI-DYNE, INC.
604 queensbury ave.
queensbury, 
NY 
12804

Original Contact norman hall
Regulation Number 870.1200
Classification Product Code
DQO  
Date Received 03/14/2000
Decision Date 09/21/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No