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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K914979
Device Name EDM(R) INFUSION CATHETER
Applicant
Peripheral Systems Group
1395 Charleston Rd.
Mountain View,  CA  94043
Applicant Contact JESSICA AYRES
Correspondent
Peripheral Systems Group
1395 Charleston Rd.
Mountain View,  CA  94043
Correspondent Contact JESSICA AYRES
Regulation Number870.1210
Classification Product Code
KRA  
Date Received11/06/1991
Decision Date 09/16/1992
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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