Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221

K-Number: K052570 · 2006-01-17

ApplicantCardiacassist, Inc.
Decision Date2006-01-17
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiacassist, Inc.. It received FDA 510(k) clearance on 2006-01-17 under 510(k) number K052570. 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 SET-EF, MODEL 5140-6221?

TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 is a medical device that received FDA 510(k) clearance on 2006-01-17. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K052570.

When did TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 receive FDA 510(k) clearance?

TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 received FDA 510(k) clearance on 2006-01-17, under 510(k) number K052570.

Who is the listed applicant for TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221?

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 SET-EF, MODEL 5140-6221?

The FDA product code for TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 is DWF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cardiacassist, Inc. 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.

K233736LifeSPARC SystemK232480ProtekDuo Veno-Venous Cannula SetsK232132LifeSPARC SystemK211830LifeSPARC SystemK202751TandemHeart Pump and Escort ControllerK183623LifeSPARC Pump, LifeSPARC Controller

View all 18 devices →

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.

↑