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FDA 510(k)

MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.

K-Number: K013013 · 2001-12-04

ApplicantMedtronic Cardiac Surgical Products
Decision Date2001-12-04
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Cardiac Surgical Products. It received FDA 510(k) clearance on 2001-12-04 under 510(k) number K013013. 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 MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.?

MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. is a medical device that received FDA 510(k) clearance on 2001-12-04. The listed applicant is Medtronic Cardiac Surgical Products. The 510(k) number is K013013.

When did MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. receive FDA 510(k) clearance?

MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. received FDA 510(k) clearance on 2001-12-04, under 510(k) number K013013.

Who is the listed applicant for MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.?

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

What is the FDA product code for MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.?

The FDA product code for MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. is DWF.

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Other records listing Medtronic Cardiac Surgical Products as applicant

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.

K022272MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)K01214324 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524K010737SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924K000776MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIPK994171MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAEK000274EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE

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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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