FDA 510(k)

A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED

K-Number: K882230 · 1988-07-29

Decision Date1988-07-29

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED is the device name listed in this FDA 510(k) record. The listed applicant is Therex Corp.. It received FDA 510(k) clearance on 1988-07-29 under 510(k) number K882230. 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 A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED?

A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED is a medical device that received FDA 510(k) clearance on 1988-07-29. The listed applicant is Therex Corp.. The 510(k) number is K882230.

When did A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED receive FDA 510(k) clearance?

A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED received FDA 510(k) clearance on 1988-07-29, under 510(k) number K882230.

Who is the listed applicant for A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED?

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

What is the FDA product code for A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED?

The FDA product code for A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED is LJT.

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Other records listing Therex Corp. as applicant

K953110LOW PROFILE TITANIUM MODEL CATALOG #1003 K953017LOW PROFILE TITANIUM MODEL CATALOG #1003 K952537THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D.K950212A2 DETACHED DUAL PORT SYSTEM K9501311.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL K942412THEREX LOW-PROFILE PORT - TITANIUM MODEL

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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.