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FDA 510(k)

TANDEMHEART FEMORAL ARTERIAL CANNULA SET

K-Number: K120543 · 2012-05-30

ApplicantCardiacassist, Inc.
Decision Date2012-05-30
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TANDEMHEART FEMORAL ARTERIAL CANNULA SET is the device name listed in this FDA 510(k) record. The listed applicant is Cardiacassist, Inc.. It received FDA 510(k) clearance on 2012-05-30 under 510(k) number K120543. 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 TANDEMHEART FEMORAL ARTERIAL CANNULA SET?

TANDEMHEART FEMORAL ARTERIAL CANNULA SET is a medical device that received FDA 510(k) clearance on 2012-05-30. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K120543.

When did TANDEMHEART FEMORAL ARTERIAL CANNULA SET receive FDA 510(k) clearance?

TANDEMHEART FEMORAL ARTERIAL CANNULA SET received FDA 510(k) clearance on 2012-05-30, under 510(k) number K120543.

Who is the listed applicant for TANDEMHEART FEMORAL ARTERIAL CANNULA SET?

The FDA 510(k) record lists Cardiacassist, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TANDEMHEART FEMORAL ARTERIAL CANNULA SET?

The FDA product code for TANDEMHEART FEMORAL ARTERIAL CANNULA SET is DWF.

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Other records listing Cardiacassist, Inc. 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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