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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 K082094
Device Name BARD PTFE (TEFLON) COATED GUIDE WIRES
Applicant
C.R. Bard Inc., Bard Electrophysiology Division
55 Technology Dr.
Lowell,  MA  01851
Applicant Contact DEBORAH L HERRINGTON
Correspondent
C.R. Bard Inc., Bard Electrophysiology Division
55 Technology Dr.
Lowell,  MA  01851
Correspondent Contact DEBORAH L HERRINGTON
Regulation Number870.1330
Classification Product Code
DQX  
Date Received07/24/2008
Decision Date 12/17/2008
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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