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FDA 510(k)

OutFlo Aortic Valve Dilatation Balloon Catheter

K-Number: K241562 · 2025-03-11

ApplicantDisa Medinotec
Decision Date2025-03-11
Product CodeOZT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OutFlo Aortic Valve Dilatation Balloon Catheter is a medical device manufactured by Disa Medinotec. It received FDA 510(k) clearance on 2025-03-11 under approval number K241562. The device is classified under product code OZT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OutFlo Aortic Valve Dilatation Balloon Catheter?

OutFlo Aortic Valve Dilatation Balloon Catheter is a medical device that received FDA 510(k) clearance on 2025-03-11. It is manufactured by Disa Medinotec. The 510(k) number is K241562.

When was OutFlo Aortic Valve Dilatation Balloon Catheter approved by the FDA?

OutFlo Aortic Valve Dilatation Balloon Catheter received FDA 510(k) clearance on 2025-03-11, under approval number K241562.

What company makes OutFlo Aortic Valve Dilatation Balloon Catheter?

OutFlo Aortic Valve Dilatation Balloon Catheter is manufactured by Disa Medinotec.

What is the FDA product code for OutFlo Aortic Valve Dilatation Balloon Catheter?

The FDA product code for OutFlo Aortic Valve Dilatation Balloon Catheter is OZT.

Related Clinical Trials

NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT06872905 Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease RECRUITING NCT06777368 REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE RECRUITING NCT07601763 Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) RECRUITING NCT07588399 STRATegy SUccesS in High-Risk PCI With Impella CP: Evaluation of Hemodynamic Protection in Complex PCI NOT_YET_RECRUITING NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41804390 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. Medical devices (Auckland, N.Z.) (2026) PMID: 41358283 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. medRxiv : the preprint server for health sciences (2025) PMID: 41114311 From bench to bedside and back: translational cardiovascular interventions in veterinary medicine. Postepy w kardiologii interwencyjnej = Advances in interventional cardiology (2025) PMID: 40278172 A Narrative Review of the Evidence for Transcatheter Aortic Valve Implants. Journal of cardiovascular development and disease (2025)

Other Devices by Disa Medinotec

K211894Trachealator

Related Devices (Code: OZT)

K152613True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc. K172932True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc. K220881INOUE BALLOON AToray Industries, Inc. K231814ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc. K240967ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc. K253855KardiaPSI Balloon CatheterIntervention Tech, Inc. ; dba Corvention

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.

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