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FDA 510(k)

DLP™ Silicone Coronary Artery Ostial Cannulae

K-Number: K230960 · 2023-05-04

ApplicantMedtronic, Inc.
Decision Date2023-05-04
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DLP™ Silicone Coronary Artery Ostial Cannulae is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K230960. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DLP™ Silicone Coronary Artery Ostial Cannulae?

DLP™ Silicone Coronary Artery Ostial Cannulae is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Medtronic, Inc.. The 510(k) number is K230960.

When did DLP™ Silicone Coronary Artery Ostial Cannulae receive FDA 510(k) clearance?

DLP™ Silicone Coronary Artery Ostial Cannulae received FDA 510(k) clearance on 2023-05-04, under 510(k) number K230960.

Who is the listed applicant for DLP™ Silicone Coronary Artery Ostial Cannulae?

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

What is the FDA product code for DLP™ Silicone Coronary Artery Ostial Cannulae?

The FDA product code for DLP™ Silicone Coronary Artery Ostial Cannulae is DWF.

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Related Devices (Code: DWF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.

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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