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)

TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500

K-Number: K061369 · 2006-08-22

ApplicantCardiacassist, Inc.
Decision Date2006-08-22
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiacassist, Inc.. It received FDA 510(k) clearance on 2006-08-22 under 510(k) number K061369. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500?

TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 is a medical device that received FDA 510(k) clearance on 2006-08-22. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K061369.

When did TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 receive FDA 510(k) clearance?

TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 received FDA 510(k) clearance on 2006-08-22, under 510(k) number K061369.

Who is the listed applicant for TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500?

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 TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500?

The FDA product code for TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 is DWA.

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: DWA)

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.

K232788INSPIRA ART100Inspira Technologies Oxy B.H.N. , Ltd.K230698Anivia SG1000 Pump ConsoleApmtd, Inc.K221491Anivia SG1000 Pump ConsoleApmtd, Inc.K192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureSpectrum Medical , Ltd.K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula KitAbbott (Formerly Thoratec Corporation)K191557CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott)

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.

↑