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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K020733
Device Name PVS 1500 SDS
Applicant
Precision Vascular Systems, Inc.
2405 W. Orton Cir.
West Valley City,  UT  84119
Applicant Contact RICK GAYKOWSKI
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NED DEVINE
Regulation Number870.1210
Classification Product Code
KRA  
Date Received03/06/2002
Decision Date 03/21/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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