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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K871492
Device Name AIS ANGIOSCOPE
Applicant
Advanced Interventional Systems, Inc.
3180 Pullman St.
Costa Mesa,  CA  92626
Applicant Contact THERESA M NEWTON
Correspondent
Advanced Interventional Systems, Inc.
3180 Pullman St.
Costa Mesa,  CA  92626
Correspondent Contact THERESA M NEWTON
Regulation Number870.1330
Classification Product Code
DQX  
Date Received04/16/1987
Decision Date 09/14/1987
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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