Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL

K-Number: K950131 · 1995-03-23

ApplicantTherex Corp.
Decision Date1995-03-23
Product CodeLJT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL is the device name listed in this FDA 510(k) record. The listed applicant is Therex Corp.. It received FDA 510(k) clearance on 1995-03-23 under 510(k) number K950131. 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 1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL?

1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL is a medical device that received FDA 510(k) clearance on 1995-03-23. The listed applicant is Therex Corp.. The 510(k) number is K950131.

When did 1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL receive FDA 510(k) clearance?

1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL received FDA 510(k) clearance on 1995-03-23, under 510(k) number K950131.

Who is the listed applicant for 1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL?

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 1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL?

The FDA product code for 1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Therex Corp. as applicant

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.

K953110LOW PROFILE TITANIUM MODEL CATALOG #1003K953017LOW PROFILE TITANIUM MODEL CATALOG #1003K952537THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D.K950212A2 DETACHED DUAL PORT SYSTEMK942412THEREX LOW-PROFILE PORT - TITANIUM MODELK934802THEREX LOW-PROFILE PORT-TITANIUM

View all 26 devices →

Related Devices (Code: LJT)

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.

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.

↑