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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 K022762
Device Name JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050
Applicant
Jomed, Inc.
15330 Ave. Of Science
Suite 200
San Diego,  CA  92128
Applicant Contact TERRY SCHULTZ
Correspondent
Jomed, Inc.
15330 Ave. Of Science
Suite 200
San Diego,  CA  92128
Correspondent Contact TERRY SCHULTZ
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/20/2002
Decision Date 12/16/2002
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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