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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K261792
Device Name DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent
Applicant
Medtronic
8200 Coral Sea St. NE
Mounds View,  MN  55112
Applicant Contact Lara Ouillette
Correspondent
Medtronic
8200 Coral Sea St. NE
Mounds View,  MN  55112
Correspondent Contact Lara Ouillette
Date Received05/29/2026
Decision Date 10/23/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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