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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 K854912
Device Name ANGIOMED GUIED WIRES
Applicant
Angiomed U.S., Inc.
4081 E. La Palma Ave.,
Suite E
Anaheim,  CA  92807
Applicant Contact RICHARD P MOHR
Correspondent
Angiomed U.S., Inc.
4081 E. La Palma Ave.,
Suite E
Anaheim,  CA  92807
Correspondent Contact RICHARD P MOHR
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/09/1985
Decision Date 04/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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