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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K910965
Device Name ECHOMARK CSI INTERFACE
Applicant
Catheter Sciences Co.
2549 U.S. Rte. 1 Rd. #1
North Brunswick,  NJ  08902
Applicant Contact FRANK DEBERNARDIS
Correspondent
Catheter Sciences Co.
2549 U.S. Rte. 1 Rd. #1
North Brunswick,  NJ  08902
Correspondent Contact FRANK DEBERNARDIS
Regulation Number870.1250
Classification Product Code
LIT  
Date Received03/06/1991
Decision Date 09/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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