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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K862030
Device Name POLY-TECH ANGIOGRAPHY CATHETER
Applicant
Poly-Tech Medical Device Research & Development
2114 N. Gordon St.
Alvin,  TX  77511
Applicant Contact WIJAY, PH.D.
Correspondent
Poly-Tech Medical Device Research & Development
2114 N. Gordon St.
Alvin,  TX  77511
Correspondent Contact WIJAY, PH.D.
Regulation Number870.1200
Classification Product Code
DQO  
Date Received05/28/1986
Decision Date 08/08/1986
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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