CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)


Device Classification Name

wire, guide, catheter

510(k) Number K121398
Device Name CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)
Applicant
GUIDEPATH MEDICAL, INC.
2621 ridgepoint dr. ste 100
austin, 
TX 
78754

Applicant Contact john mitchell tatum
Correspondent
GUIDEPATH MEDICAL, INC.
2621 ridgepoint dr. ste 100
austin, 
TX 
78754

Correspodent Contact john mitchell tatum
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 05/09/2012
Decision Date 12/13/2012
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