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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, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K870403
Device Name CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE
Applicant
Burron Medical Products, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Applicant Contact TRACEY CONNOLLY
Correspondent
Burron Medical Products, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Correspondent Contact TRACEY CONNOLLY
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/02/1987
Decision Date 05/01/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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