ANCHORWIRE GUIDEWIRE


Device Classification Name

wire, guide, catheter

510(k) Number K111288
Device Name ANCHORWIRE GUIDEWIRE
Applicant
LAKE REGION MEDICAL
340 lake hazeltine drive
chaska, 
MN 
55318

Applicant Contact mathew pexa
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 05/06/2011
Decision Date 08/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No