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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wire, guide, catheter
510(k) Number K121398
Model 150RA, 180RA, 260RA, 150RS, 180RS, 260RS, 150SA, 180SA, 260SA, 150SS, 180SS, 260SS
Device Name CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)
Original Applicant
GUIDEPATH MEDICAL, INC.
2621 ridgepoint dr. ste 100
austin,  TX  78754
Original Contact john mitchell tatum
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/09/2012
Decision Date 12/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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