FDA 510(k)

TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)

K-Number: K954258 · 1996-05-24

ApplicantGerard Medical Enterprises, Inc.

Decision Date1996-05-24

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) 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 1996-05-24 under 510(k) number K954258. 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 TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)?

TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1996-05-24. The listed applicant is Gerard Medical Enterprises, Inc.. The 510(k) number is K954258.

When did TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) receive FDA 510(k) clearance?

TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) received FDA 510(k) clearance on 1996-05-24, under 510(k) number K954258.

Who is the listed applicant for TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)?

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 TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)?

The FDA product code for TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) is LJT.

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Other records listing Gerard Medical Enterprises, Inc. as applicant

K945250TRIMPORT K942623TRIMPORT K922147DUAL PLASTIC VASCULAR ACCESS SYSTEM K913114TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT K912111MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE K903364GERARD MEDICAL, INC. TRIM-PORT

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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

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