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FDA 510(k)

Multistage Balloon Dilatation Catheter

K-Number: K222187 · 2023-03-01

ApplicantDongguan TT Medical, Inc.
Decision Date2023-03-01
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Multistage Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan TT Medical, Inc.. It received FDA 510(k) clearance on 2023-03-01 under 510(k) number K222187. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Multistage Balloon Dilatation Catheter?

Multistage Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2023-03-01. The listed applicant is Dongguan TT Medical, Inc.. The 510(k) number is K222187.

When did Multistage Balloon Dilatation Catheter receive FDA 510(k) clearance?

Multistage Balloon Dilatation Catheter received FDA 510(k) clearance on 2023-03-01, under 510(k) number K222187.

Who is the listed applicant for Multistage Balloon Dilatation Catheter?

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

What is the FDA product code for Multistage Balloon Dilatation Catheter?

The FDA product code for Multistage Balloon Dilatation Catheter is KTI.

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.

NCT05509296Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery DiseaseCOMPLETEDNCT06832631VITUS Post-Market RegistryACTIVE_NOT_RECRUITINGNCT07397390an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified LesionsENROLLING_BY_INVITATION

Other records listing Dongguan TT Medical, 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.

K260437Valvuloplasty Balloon Catheter (ValvuloPro)K240967ValvuloPro Valvuloplasty Balloon CatheterK231814ValvuloPro Valvuloplasty Balloon CatheterK230374Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)K222663MultiStage Balloon Dilatation Catheter

Related Devices (Code: KTI)

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.

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm ScopesCook Ireland, Ltd.K251478ClearTip TBNA TypeFinemedix Co., Ltd.K254040LungFlow Basket CatheterFree Flow Medical, Inc.K251402LIA-1 Catheter (542-1)Leadoptik, Inc.K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc.K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation

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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