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FDA 510(k)

TANDEMHEART TRANSSEPTAL CANNULA- EF 72

K-Number: K082425 · 2008-09-18

ApplicantCardiacassist, Inc.
Decision Date2008-09-18
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TANDEMHEART TRANSSEPTAL CANNULA- EF 72 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiacassist, Inc.. It received FDA 510(k) clearance on 2008-09-18 under 510(k) number K082425. 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 TRANSSEPTAL CANNULA- EF 72?

TANDEMHEART TRANSSEPTAL CANNULA- EF 72 is a medical device that received FDA 510(k) clearance on 2008-09-18. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K082425.

When did TANDEMHEART TRANSSEPTAL CANNULA- EF 72 receive FDA 510(k) clearance?

TANDEMHEART TRANSSEPTAL CANNULA- EF 72 received FDA 510(k) clearance on 2008-09-18, under 510(k) number K082425.

Who is the listed applicant for TANDEMHEART TRANSSEPTAL CANNULA- EF 72?

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 TRANSSEPTAL CANNULA- EF 72?

The FDA product code for TANDEMHEART TRANSSEPTAL CANNULA- EF 72 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.

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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