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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K260459
Device Name VANES Delivery System (VDS)
Applicant
Zoll Respicardia, Inc.
12400 Whitewater Dr.
Suite 150
Minnetonka,  MN  55343
Applicant Contact Abby VanHaren
Correspondent
Zoll Respicardia, Inc.
12400 Whitewater Dr.
Suite 150
Minnetonka,  MN  55343
Correspondent Contact Kevin Bentley
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/11/2026
Decision Date 04/06/2026
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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