FDA 510(k)

A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT

K-Number: K921379 · 1992-11-06

Decision Date1992-11-06

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT is the device name listed in this FDA 510(k) record. The listed applicant is Therex Corp.. It received FDA 510(k) clearance on 1992-11-06 under 510(k) number K921379. 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 IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT?

A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT is a medical device that received FDA 510(k) clearance on 1992-11-06. The listed applicant is Therex Corp.. The 510(k) number is K921379.

When did A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT receive FDA 510(k) clearance?

A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT received FDA 510(k) clearance on 1992-11-06, under 510(k) number K921379.

Who is the listed applicant for A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT?

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 IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT?

The FDA product code for A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT 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.