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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 the device name listed in this FDA 510(k) record. The listed applicant is Disa Medinotec. It received FDA 510(k) clearance on 2025-03-11 under 510(k) 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. The listed applicant is Disa Medinotec. The 510(k) number is K241562.

When did OutFlo Aortic Valve Dilatation Balloon Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for OutFlo Aortic Valve Dilatation Balloon Catheter?

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

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

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.

NCT06816485INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic StenosisRECRUITINGNCT07614100Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding ValvesNOT_YET_RECRUITINGNCT04722250SMall Annuli Randomized To Evolut™ or SAPIEN™ TrialACTIVE_NOT_RECRUITINGNCT05172960ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart ValveRECRUITINGNCT05172973ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic ValvesRECRUITINGNCT05509296Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery DiseaseCOMPLETED

Other records listing Disa Medinotec 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.

K211894Trachealator

Related Devices (Code: OZT)

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.

K253855KardiaPSI Balloon CatheterIntervention Tech, Inc. ; dba CorventionK260437Valvuloplasty Balloon Catheter (ValvuloPro)Dongguan TT Medical, Inc.K240967ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc.K231814ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc.K220881INOUE BALLOON AToray Industries, Inc.K172932True Flow Valvuloplasty Perfusion CatheterC.R. Bard, 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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