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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
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
Correspondent Contact JOHN MITCHELL TATUM
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/09/2012
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
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