FDA 510(k)

DUAL PLASTIC VASCULAR ACCESS SYSTEM

K-Number: K922147 · 1992-12-04

ApplicantGerard Medical Enterprises, Inc.

Decision Date1992-12-04

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DUAL PLASTIC VASCULAR ACCESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gerard Medical Enterprises, Inc.. It received FDA 510(k) clearance on 1992-12-04 under 510(k) number K922147. 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 DUAL PLASTIC VASCULAR ACCESS SYSTEM?

DUAL PLASTIC VASCULAR ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 1992-12-04. The listed applicant is Gerard Medical Enterprises, Inc.. The 510(k) number is K922147.

When did DUAL PLASTIC VASCULAR ACCESS SYSTEM receive FDA 510(k) clearance?

DUAL PLASTIC VASCULAR ACCESS SYSTEM received FDA 510(k) clearance on 1992-12-04, under 510(k) number K922147.

Who is the listed applicant for DUAL PLASTIC VASCULAR ACCESS SYSTEM?

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

What is the FDA product code for DUAL PLASTIC VASCULAR ACCESS SYSTEM?

The FDA product code for DUAL PLASTIC VASCULAR ACCESS SYSTEM 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Gerard Medical Enterprises, Inc. as applicant

K954258TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)K945250TRIMPORT K942623TRIMPORT K913114TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT K912111MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE K903364GERARD MEDICAL, INC. TRIM-PORT

View all 8 devices →

Related Devices (Code: LJT)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.