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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 K922787
Device Name ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION
Applicant
Echocath, Inc.
P.O. Box 7224
Princeton,  NJ  08543
Applicant Contact DE BERNARDIS
Correspondent
Echocath, Inc.
P.O. Box 7224
Princeton,  NJ  08543
Correspondent Contact DE BERNARDIS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/09/1992
Decision Date 01/06/1993
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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