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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K912984
Device Name OPTI-PLAST 5F PTA CATHETERS, MODIFICATION
Applicant
Vas-Cath, Inc.
2380 Tedlo St.
Mississauga, Ontario,  CA L5A 3V3
Applicant Contact MARCO A GUILLEN
Correspondent
Vas-Cath, Inc.
2380 Tedlo St.
Mississauga, Ontario,  CA L5A 3V3
Correspondent Contact MARCO A GUILLEN
Regulation Number870.1250
Classification Product Code
LIT  
Date Received06/28/1991
Decision Date 08/13/1991
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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