FDA 510(k)

SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM

K-Number: K890518 · 1989-04-21

Decision Date1989-04-21

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Harbor Medical Devices, Inc.. It received FDA 510(k) clearance on 1989-04-21 under 510(k) number K890518. 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 SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM?

SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 1989-04-21. The listed applicant is Harbor Medical Devices, Inc.. The 510(k) number is K890518.

When did SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM receive FDA 510(k) clearance?

SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM received FDA 510(k) clearance on 1989-04-21, under 510(k) number K890518.

Who is the listed applicant for SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM?

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

What is the FDA product code for SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM?

The FDA product code for SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM is LJT.

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Other records listing Harbor Medical Devices, Inc. as applicant

K884628HARBORIN CENTRAL VENOUS CATHETER K882657HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT K881884HARBOR CENTRAL VENOUS CATHETER K882190S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM K880297SEA - PORT INFUSION SET K874414HYPODERMIC NEEDLES, SINGLE LUMEN

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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.