STEERABLE GUIDEWIRE


Device Classification Name

wire, guide, catheter

510(k) Number K022813
Device Name STEERABLE GUIDEWIRE
Original Applicant
LAKE REGION MFG., INC.
340 lake hazeltine dr.
chaska, 
MN 
55318

Original Contact karen mortensen
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 08/26/2002
Decision Date 02/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No