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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 K852791
Device Name 7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS
Applicant
Cardio-Vascular Innovations, Inc.
13905 Willard Rd.
P.O. Box 269
Chantilly,  VA  22021
Applicant Contact DANIEL W SAWYER
Correspondent
Cardio-Vascular Innovations, Inc.
13905 Willard Rd.
P.O. Box 269
Chantilly,  VA  22021
Correspondent Contact DANIEL W SAWYER
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/01/1985
Decision Date 11/05/1985
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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