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FDA 510(k)

Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae

K-Number: K162215 · 2017-06-16

ApplicantSorin Group Italia S.R.L.
Decision Date2017-06-16
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aortic Arch Cannulae, Optiflow Aortic Arch 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 2017-06-16 under 510(k) number K162215. 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 Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae?

Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae is a medical device that received FDA 510(k) clearance on 2017-06-16. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K162215.

When did Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae receive FDA 510(k) clearance?

Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae received FDA 510(k) clearance on 2017-06-16, under 510(k) number K162215.

Who is the listed applicant for Aortic Arch Cannulae, Optiflow Aortic Arch 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 Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae?

The FDA product code for Aortic Arch Cannulae, Optiflow Aortic Arch 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.

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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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