HI TORQUE CONNECT GUIDEWIRE


Device Classification Name

wire, guide, catheter

510(k) Number K112381
Device Name HI TORQUE CONNECT GUIDEWIRE
Applicant
LAKE REGION MEDICAL
lake region med intl r&d ctr
parkmore west business
galway, 

IE

ei

Applicant Contact kenny walsh
Correspondent
LAKE REGION MEDICAL
lake region med intl r&d ctr
parkmore west business
galway, 

IE

ei

Correspodent Contact kenny walsh
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 08/17/2011
Decision Date 11/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls