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FDA 510(k)

THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012

K-Number: K974475 · 1998-03-02

ApplicantBiocontrol Technology, Inc.
Decision Date1998-03-02
Product CodeLJT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 is the device name listed in this FDA 510(k) record. The listed applicant is Biocontrol Technology, Inc.. It received FDA 510(k) clearance on 1998-03-02 under 510(k) number K974475. 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 THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012?

THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 is a medical device that received FDA 510(k) clearance on 1998-03-02. The listed applicant is Biocontrol Technology, Inc.. The 510(k) number is K974475.

When did THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 receive FDA 510(k) clearance?

THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 received FDA 510(k) clearance on 1998-03-02, under 510(k) number K974475.

Who is the listed applicant for THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012?

The FDA 510(k) record lists Biocontrol Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012?

The FDA product code for THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 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.

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Other records listing Biocontrol Technology, Inc. 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.

K960350THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602

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

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