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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 K002627
Device Name ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
Applicant
Atrium Medical Corp.
5 Wentworth Dr.
Hudson,  NH  03051
Applicant Contact REBECCA DOLLOFF
Correspondent
Atrium Medical Corp.
5 Wentworth Dr.
Hudson,  NH  03051
Correspondent Contact REBECCA DOLLOFF
Regulation Number870.5150
Classification Product Code
DXE  
Date Received08/23/2000
Decision Date 04/26/2001
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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