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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 K822245
Device Name INDEFLATOR
Applicant
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
Santa Clara,  CA  95054
Correspondent
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
Santa Clara,  CA  95054
Regulation Number870.1250
Classification Product Code
LIT  
Date Received07/29/1982
Decision Date 08/31/1982
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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