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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Infusion
510(k) Number K863982
Device Name VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY
Applicant
Vas-Cath of Canada , Ltd.
2380 Tedlo St. Mississauga
Ontario, L5a 3v3,  CA
Applicant Contact KATHERINE H CREWE
Correspondent
Vas-Cath of Canada , Ltd.
2380 Tedlo St. Mississauga
Ontario, L5a 3v3,  CA
Correspondent Contact KATHERINE H CREWE
Regulation Number878.4200
Classification Product Code
JCY  
Date Received10/14/1986
Decision Date 10/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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