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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Intravascular, Cardiovascular
510(k) Number K874096
Device Name TITANIUM GREENFIELD VENA CAVA FILTER CARRIER
Applicant
Medi-Tech, Inc.
480 Plesant St.
P.O. Box 7407
Watertown,  MA  02272
Applicant Contact P SEPRINSKI
Correspondent
Medi-Tech, Inc.
480 Plesant St.
P.O. Box 7407
Watertown,  MA  02272
Correspondent Contact P SEPRINSKI
Regulation Number870.3375
Classification Product Code
DTK  
Date Received10/08/1987
Decision Date 11/04/1988
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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