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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K911333
Device Name RIGHT ATRIAL CATHETERS
Applicant
Akcess Medical Products, Inc.
789 Jersey Ave.
New Brunswick,  NJ  08901
Applicant Contact BALBIR B KAPANY
Correspondent
Akcess Medical Products, Inc.
789 Jersey Ave.
New Brunswick,  NJ  08901
Correspondent Contact BALBIR B KAPANY
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/26/1991
Decision Date 09/23/1991
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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