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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Embolectomy
510(k) Number K910372
Device Name INTIMAX THROMBECTOMY CATHETER
Applicant
APPLIED VASCULAR DEVICES, INC.
26051 MERIT CIRCLE, #104
LAGUNA HILLS,  CA  92653
Applicant Contact JO STEGWELL
Correspondent
APPLIED VASCULAR DEVICES, INC.
26051 MERIT CIRCLE, #104
LAGUNA HILLS,  CA  92653
Correspondent Contact JO STEGWELL
Regulation Number870.5150
Classification Product Code
DXE  
Date Received01/29/1991
Decision Date 04/26/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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