FDA 510(k)

VASCULAR ACCESS PORT KIT

K-Number: K955587 · 1996-03-21

Decision Date1996-03-21

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

VASCULAR ACCESS PORT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1996-03-21 under 510(k) number K955587. 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 VASCULAR ACCESS PORT KIT?

VASCULAR ACCESS PORT KIT is a medical device that received FDA 510(k) clearance on 1996-03-21. The listed applicant is Boston Scientific Corp. The 510(k) number is K955587.

When did VASCULAR ACCESS PORT KIT receive FDA 510(k) clearance?

VASCULAR ACCESS PORT KIT received FDA 510(k) clearance on 1996-03-21, under 510(k) number K955587.

Who is the listed applicant for VASCULAR ACCESS PORT KIT?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VASCULAR ACCESS PORT KIT?

The FDA product code for VASCULAR ACCESS PORT KIT is LJT.

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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.