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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K963611
Device Name VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH
Applicant
Vascutek, Ltd.
1300 E. Anderson Ln.
Austin,  TX  78752
Applicant Contact TEENA M AUGOSTINO
Correspondent
Vascutek, Ltd.
1300 E. Anderson Ln.
Austin,  TX  78752
Correspondent Contact TEENA M AUGOSTINO
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received09/10/1996
Decision Date 11/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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