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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 K941706
Device Name OPTI-PLAST ANGIOPLASTY CATHETER
Applicant
Vas-Cath, Inc.
2380 Tedlo St.
Mississauga, Ontario,  CA L5A 3V3
Applicant Contact ANGELA J ACITO
Correspondent
Vas-Cath, Inc.
2380 Tedlo St.
Mississauga, Ontario,  CA L5A 3V3
Correspondent Contact ANGELA J ACITO
Regulation Number870.1250
Classification Product Code
LIT  
Date Received04/06/1994
Decision Date 10/18/1994
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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