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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K952984
Device Name MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F)
Applicant
Map Medical Equipment, Inc.
10750 U.S. Hwy. Ii
North Lawrence,  NY  12967
Applicant Contact MICHAEL L MARTIN
Correspondent
Map Medical Equipment, Inc.
10750 U.S. Hwy. Ii
North Lawrence,  NY  12967
Correspondent Contact MICHAEL L MARTIN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/28/1995
Decision Date 01/29/1996
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
Recalls CDRH Recalls
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