FDA 510(k)

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

K-Number: K960350 · 1996-04-15

Decision Date1996-04-15

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602 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 1996-04-15 under 510(k) number K960350. 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 VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602?

THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602 is a medical device that received FDA 510(k) clearance on 1996-04-15. The listed applicant is Biocontrol Technology, Inc.. The 510(k) number is K960350.

When did THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602 receive FDA 510(k) clearance?

THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602 received FDA 510(k) clearance on 1996-04-15, under 510(k) number K960350.

Who is the listed applicant for THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602?

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

The FDA product code for THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602 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

K974475THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012

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.