Device Classification Name	Wire, Guide, Catheter
510(k) Number	K123067
Device Name	PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY
Applicant	Abbott Vascular, Inc. P.O. Box 9018 Temecula,  CA  92591
Applicant Contact	SEAN MULLIN
Correspondent	Abbott Vascular, Inc. P.O. Box 9018 Temecula,  CA  92591
Correspondent Contact	SEAN MULLIN
Regulation Number	870.1330
Classification Product Code	DQX
Date Received	10/01/2012
Decision Date	01/29/2013
Decision	Substantially Equivalent (SESE)
Regulation Medical Specialty	Cardiovascular
510k Review Panel	Cardiovascular
Summary	Summary
Type	Traditional
Clinical Trials	NCT01435031
Reviewed by Third Party	No
Combination Product	No
Predetermined Change Control Plan Authorized	No