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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 K922609
Device Name ITC CATHETERS W/ HYDROMER
Applicant
Interventional Therapeutics Corp.
385 Oyster Pt. Blvd., Suite #6
South San Francisco,  CA  94080
Applicant Contact LUANNE TERMEER
Correspondent
Interventional Therapeutics Corp.
385 Oyster Pt. Blvd., Suite #6
South San Francisco,  CA  94080
Correspondent Contact LUANNE TERMEER
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/02/1992
Decision Date 04/30/1993
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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