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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 K122573
Device Name HI-TORQUE COMMAND GUIDE WIRE FAMILY
Applicant
Abbott Vascular, Inc.
26531 Ynez Rd., Bldg. G
Maling P.O. 9018
Temecula,  CA  92590
Applicant Contact KAY SETZER
Correspondent
Abbott Vascular, Inc.
26531 Ynez Rd., Bldg. G
Maling P.O. 9018
Temecula,  CA  92590
Correspondent Contact KAY SETZER
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/23/2012
Decision Date 11/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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