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FDA 510(k)

LOW PROFILE TITANIUM MODEL CATALOG #1003

K-Number: K953110 · 1995-09-13

ApplicantTherex Corp.
Decision Date1995-09-13
Product CodeLJT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LOW PROFILE TITANIUM MODEL CATALOG #1003 is the device name listed in this FDA 510(k) record. The listed applicant is Therex Corp.. It received FDA 510(k) clearance on 1995-09-13 under 510(k) number K953110. 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 LOW PROFILE TITANIUM MODEL CATALOG #1003?

LOW PROFILE TITANIUM MODEL CATALOG #1003 is a medical device that received FDA 510(k) clearance on 1995-09-13. The listed applicant is Therex Corp.. The 510(k) number is K953110.

When did LOW PROFILE TITANIUM MODEL CATALOG #1003 receive FDA 510(k) clearance?

LOW PROFILE TITANIUM MODEL CATALOG #1003 received FDA 510(k) clearance on 1995-09-13, under 510(k) number K953110.

Who is the listed applicant for LOW PROFILE TITANIUM MODEL CATALOG #1003?

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 LOW PROFILE TITANIUM MODEL CATALOG #1003?

The FDA product code for LOW PROFILE TITANIUM MODEL CATALOG #1003 is LJT.

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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.

K953017LOW PROFILE TITANIUM MODEL CATALOG #1003K952537THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D.K950212A2 DETACHED DUAL PORT SYSTEMK9501311.0MM 1.8MMO.D. POLYURETHANE DETACHED MODELK942412THEREX LOW-PROFILE PORT - TITANIUM MODELK934802THEREX LOW-PROFILE PORT-TITANIUM

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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.

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