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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 K951159
Device Name FASGUIDE
Applicant
Target Therapeutics
47201 Lakeview Blvd.
P.O. Box 5120
Freemont,  CA  94538
Applicant Contact LARAINE PANGELINA
Correspondent
Target Therapeutics
47201 Lakeview Blvd.
P.O. Box 5120
Freemont,  CA  94538
Correspondent Contact LARAINE PANGELINA
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/14/1995
Decision Date 09/25/1995
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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