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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, Long-Term Greater Than 30 Days
510(k) Number K973057
Device Name 1.4 FR MAPCATH SENSOR STYLET
Applicant
Navion Biomedical Corp.
312 Tosca Dr.
Stoughton,  MA  02072
Applicant Contact DONALD A KAY
Correspondent
Navion Biomedical Corp.
312 Tosca Dr.
Stoughton,  MA  02072
Correspondent Contact DONALD A KAY
Regulation Number880.5970
Classification Product Code
LJS  
Date Received08/15/1997
Decision Date 11/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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