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FDA 510(k)

In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath

K-Number: K201165 · 2020-12-17

ApplicantColoplast Corp.
Decision Date2020-12-17
Product CodeLJE
DecisionUnknown

Device Summary

In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath is a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2020-12-17 under approval number K201165. The device is classified under product code LJE. FDA Decision: Unknown.

Frequently Asked Questions

What is the In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath?

In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath is a medical device that received FDA 510(k) clearance on 2020-12-17. It is manufactured by Coloplast Corp.. The 510(k) number is K201165.

When was In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath approved by the FDA?

In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath received FDA 510(k) clearance on 2020-12-17, under approval number K201165.

What company makes In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath?

In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath is manufactured by Coloplast Corp..

What is the FDA product code for In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath?

The FDA product code for In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath is LJE.

Related Clinical Trials

NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT06353594 Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI RECRUITING NCT07587099 Single vs. Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Intervention With DCB-only Strategy (KONG-FREEDOM-I) RECRUITING NCT06795763 Acolyte CTO-PCI Study: Imaging and Catheter System to Treat Patients With Coronary Chronic Total Occlusion, Who Have Persistent Symptoms Following Medical Therapy and Are Undergoing Percutaneous Coronary Interventional Procedures ENROLLING_BY_INVITATION NCT06959524 AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions RECRUITING NCT03791970 Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries 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)

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Related Devices (Code: LJE)

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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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