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

FDA 510(k)

TubaVent Balloon Dilatation System

K-Number: K223542 · 2023-08-03

ApplicantSpiggle & Theis Medizintechnik GmbH
Decision Date2023-08-03
Product CodePNZ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TubaVent Balloon Dilatation System is a medical device manufactured by Spiggle & Theis Medizintechnik GmbH. It received FDA 510(k) clearance on 2023-08-03 under approval number K223542. The device is classified under product code PNZ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TubaVent Balloon Dilatation System?

TubaVent Balloon Dilatation System is a medical device that received FDA 510(k) clearance on 2023-08-03. It is manufactured by Spiggle & Theis Medizintechnik GmbH. The 510(k) number is K223542.

When was TubaVent Balloon Dilatation System approved by the FDA?

TubaVent Balloon Dilatation System received FDA 510(k) clearance on 2023-08-03, under approval number K223542.

What company makes TubaVent Balloon Dilatation System?

TubaVent Balloon Dilatation System is manufactured by Spiggle & Theis Medizintechnik GmbH.

What is the FDA product code for TubaVent Balloon Dilatation System?

The FDA product code for TubaVent Balloon Dilatation System is PNZ.

Related Clinical Trials

NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT07195708 Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365') NOT_YET_RECRUITING NCT07181590 BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF RECRUITING NCT07062094 Safety and Effectiveness of Orbera365™ Intragastric Balloon System RECRUITING NCT07587541 Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter NOT_YET_RECRUITING NCT07580560 Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study COMPLETED

Related Devices (Code: PNZ)

DEN150056Acclarent Aera Eustachian Tube Balloon Dilation SystemAcclarent, Inc. K163509XprESS ENT Dilation SystemEntellus Medical, Inc. K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc. K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc. K220027Audion ET dilation systemEntellus Medical, Inc. K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, 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.

↑