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FDA 510(k)

PureFlex Arterial Cannulae

K-Number: K180979 · 2018-11-16

ApplicantSorin Group Italia S.R.L.
Decision Date2018-11-16
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PureFlex Arterial Cannulae 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 2018-11-16 under 510(k) number K180979. 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 PureFlex Arterial Cannulae?

PureFlex Arterial Cannulae is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K180979.

When did PureFlex Arterial Cannulae receive FDA 510(k) clearance?

PureFlex Arterial Cannulae received FDA 510(k) clearance on 2018-11-16, under 510(k) number K180979.

Who is the listed applicant for PureFlex Arterial Cannulae?

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 PureFlex Arterial Cannulae?

The FDA product code for PureFlex Arterial Cannulae is DWF.

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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