FDA 510(k)

A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM

K-Number: K875214 · 1988-02-19

Decision Date1988-02-19

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Therex Corp.. It received FDA 510(k) clearance on 1988-02-19 under 510(k) number K875214. 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?

A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 1988-02-19. The listed applicant is Therex Corp.. The 510(k) number is K875214.

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

A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM received FDA 510(k) clearance on 1988-02-19, under 510(k) number K875214.

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

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?

The FDA product code for A PORT IMPLANTABLE 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 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

View all 26 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.