FDA 510(k)

A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM

K-Number: K893460 · 1989-06-23

Decision Date1989-06-23

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM is the device name listed in this FDA 510(k) record. The listed applicant is Therex Corp.. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K893460. 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 .6MM/2.29MM?

A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Therex Corp.. The 510(k) number is K893460.

When did A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM receive FDA 510(k) clearance?

A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM received FDA 510(k) clearance on 1989-06-23, under 510(k) number K893460.

Who is the listed applicant for A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM?

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 .6MM/2.29MM?

The FDA product code for A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM 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.