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FDA 510(k)

VACUUM ASSIST STABILIZER

K-Number: K992833 · 1999-11-10

ApplicantCardio Thoracic Systems
Decision Date1999-11-10
Product CodeMWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VACUUM ASSIST STABILIZER is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Thoracic Systems. It received FDA 510(k) clearance on 1999-11-10 under 510(k) number K992833. 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 VACUUM ASSIST STABILIZER?

VACUUM ASSIST STABILIZER is a medical device that received FDA 510(k) clearance on 1999-11-10. The listed applicant is Cardio Thoracic Systems. The 510(k) number is K992833.

When did VACUUM ASSIST STABILIZER receive FDA 510(k) clearance?

VACUUM ASSIST STABILIZER received FDA 510(k) clearance on 1999-11-10, under 510(k) number K992833.

Who is the listed applicant for VACUUM ASSIST STABILIZER?

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

What is the FDA product code for VACUUM ASSIST STABILIZER?

The FDA product code for VACUUM ASSIST STABILIZER 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 Cardio Thoracic Systems 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.

K991073ACIER SUTURESK864146DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE)

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 SurgicalK982419HEART-LIFT BALLOON POSITIONERCardiothoracic Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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