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FDA 510(k)

R501 aortic root cannula without vent line, R502 aortic root cannula with vent line

K-Number: K200612 · 2020-11-17

ApplicantSorin Group Italia S.R.L.
Decision Date2020-11-17
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

R501 aortic root cannula without vent line, R502 aortic root cannula with vent line is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2020-11-17 under 510(k) number K200612. 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 R501 aortic root cannula without vent line, R502 aortic root cannula with vent line?

R501 aortic root cannula without vent line, R502 aortic root cannula with vent line is a medical device that received FDA 510(k) clearance on 2020-11-17. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K200612.

When did R501 aortic root cannula without vent line, R502 aortic root cannula with vent line receive FDA 510(k) clearance?

R501 aortic root cannula without vent line, R502 aortic root cannula with vent line received FDA 510(k) clearance on 2020-11-17, under 510(k) number K200612.

Who is the listed applicant for R501 aortic root cannula without vent line, R502 aortic root cannula with vent line?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R501 aortic root cannula without vent line, R502 aortic root cannula with vent line?

The FDA product code for R501 aortic root cannula without vent line, R502 aortic root cannula with vent line is DWF.

Related Clinical Trials

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.

NCT07628907Post-Market Clinical Follow-up Study on the Performance and Safety of the Aortic Root Cannula Used in Cardiopulmonary Bypass SurgeryNOT_YET_RECRUITING

Other records listing Sorin Group Italia S.R.L. as applicant

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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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