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)

HEART-LIFT BALLOON POSITIONER

K-Number: K982419 · 1999-01-13

ApplicantCardiothoracic Systems, Inc.
Decision Date1999-01-13
Product CodeMWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART-LIFT BALLOON POSITIONER is the device name listed in this FDA 510(k) record. The listed applicant is Cardiothoracic Systems, Inc.. It received FDA 510(k) clearance on 1999-01-13 under 510(k) number K982419. The device is classified under product code MWS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEART-LIFT BALLOON POSITIONER?

HEART-LIFT BALLOON POSITIONER is a medical device that received FDA 510(k) clearance on 1999-01-13. The listed applicant is Cardiothoracic Systems, Inc.. The 510(k) number is K982419.

When did HEART-LIFT BALLOON POSITIONER receive FDA 510(k) clearance?

HEART-LIFT BALLOON POSITIONER received FDA 510(k) clearance on 1999-01-13, under 510(k) number K982419.

Who is the listed applicant for HEART-LIFT BALLOON POSITIONER?

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

What is the FDA product code for HEART-LIFT BALLOON POSITIONER?

The FDA product code for HEART-LIFT BALLOON POSITIONER is MWS.

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 Cardiothoracic Systems, 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.

K010117GUIDANT AXIUS CORONARY SHUNTK983270VOYAGER QUAD CANNULAK983135BLOWER/MISTERK963965CTS MIDCAB STITCHERK970638CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNTK963503CTS MIDCAB CORONARY SHUNT

View all 8 devices →

Related Devices (Code: MWS)

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.

K041338MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIESMedtronic VascularK992476PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADSPilling Weck SurgicalK992833VACUUM ASSIST STABILIZERCardio Thoracic Systems

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.

↑