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FDA 510(k)

AORTIC ARCH CANNULAS

K-Number: K943934 · 1995-06-02

ApplicantSorin Group Italia S.R.L.
Decision Date1995-06-02
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AORTIC ARCH CANNULAS 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 1995-06-02 under 510(k) number K943934. 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 CANNULAS?

AORTIC ARCH CANNULAS is a medical device that received FDA 510(k) clearance on 1995-06-02. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K943934.

When did AORTIC ARCH CANNULAS receive FDA 510(k) clearance?

AORTIC ARCH CANNULAS received FDA 510(k) clearance on 1995-06-02, under 510(k) number K943934.

Who is the listed applicant for AORTIC ARCH CANNULAS?

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 CANNULAS?

The FDA product code for AORTIC ARCH CANNULAS is DWF.

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

K253671Dual Stage Venous CannulaeK251783Inspire HCR and HCR DUAL cardiotomy reservoirsK253616ProtekDilate Vascular Access KitK250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)K243264DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)

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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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