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FDA 510(k)

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

K-Number: K261792 · 2026-10-23

ApplicantMedtronic
Decision Date2026-10-23
Product Code
DecisionSubstantially Equivalent

Device Summary

DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2026-10-23 under 510(k) number K261792. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent?

DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent is a medical device that received FDA 510(k) clearance on 2026-10-23. The listed applicant is Medtronic. The 510(k) number is K261792.

When did DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent receive FDA 510(k) clearance?

DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent received FDA 510(k) clearance on 2026-10-23, under 510(k) number K261792.

Who is the listed applicant for DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent?

The FDA 510(k) record lists Medtronic as the applicant. This does not by itself establish the device manufacturer.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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