INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX


definition

Device Classification Name

introducer, catheter

510(k) Number K002847
Device Name INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX
Original Applicant
MAXXIM MEDICAL
1445 flat creek rd.
athens, 
TX 
75751

Original Contact gail doherty
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 09/13/2000
Decision Date 05/31/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Abbreviated
Reviewed by Third Party No

Combination Product

No