510(k) clearance

DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent

FDA 510(k) source

510(k) number

K261792

Applicant

Medtronic

Decision date

Oct 23, 2026

Date received

May 29, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Advisory committee

Unknown

Statement or summary

Summary

Third party

N

Location

Mounds View, MN, US