FDA 510(k)

MEDTRONIC MODEL 8501 ACCESS PORT

K-Number: K861498 · 1986-06-12

Decision Date1986-06-12

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC MODEL 8501 ACCESS PORT is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1986-06-12 under 510(k) number K861498. 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 MEDTRONIC MODEL 8501 ACCESS PORT?

MEDTRONIC MODEL 8501 ACCESS PORT is a medical device that received FDA 510(k) clearance on 1986-06-12. The listed applicant is Medtronic Vascular. The 510(k) number is K861498.

When did MEDTRONIC MODEL 8501 ACCESS PORT receive FDA 510(k) clearance?

MEDTRONIC MODEL 8501 ACCESS PORT received FDA 510(k) clearance on 1986-06-12, under 510(k) number K861498.

Who is the listed applicant for MEDTRONIC MODEL 8501 ACCESS PORT?

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

What is the FDA product code for MEDTRONIC MODEL 8501 ACCESS PORT?

The FDA product code for MEDTRONIC MODEL 8501 ACCESS PORT 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.