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FDA 510(k)

SURECATH PORT ACCESS CATHETER

K-Number: K920036 · 1992-11-25

ApplicantIvion Corp.
Decision Date1992-11-25
Product CodeLJT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURECATH PORT ACCESS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Ivion Corp.. It received FDA 510(k) clearance on 1992-11-25 under 510(k) number K920036. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURECATH PORT ACCESS CATHETER?

SURECATH PORT ACCESS CATHETER is a medical device that received FDA 510(k) clearance on 1992-11-25. The listed applicant is Ivion Corp.. The 510(k) number is K920036.

When did SURECATH PORT ACCESS CATHETER receive FDA 510(k) clearance?

SURECATH PORT ACCESS CATHETER received FDA 510(k) clearance on 1992-11-25, under 510(k) number K920036.

Who is the listed applicant for SURECATH PORT ACCESS CATHETER?

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

What is the FDA product code for SURECATH PORT ACCESS CATHETER?

The FDA product code for SURECATH PORT ACCESS CATHETER is LJT.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ivion Corp. 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.

K925311TRILOGY INFUSION PUMPK925219IVION ADMIN SETS W/FLOW CLIPS

Related Devices (Code: LJT)

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.

K260916FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc.K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable PortBard Access Systems, Inc.K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable PortBard Access Systems, Inc.K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsBard Access Systems, Inc.K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable PortBard Peripheral Vascular, Inc.K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, 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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