FDA 510(k)

PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM

K-Number: K994216 · 2000-01-27

Decision Date2000-01-27

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sims Deltec, Inc.. It received FDA 510(k) clearance on 2000-01-27 under 510(k) number K994216. 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 PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM?

PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 2000-01-27. The listed applicant is Sims Deltec, Inc.. The 510(k) number is K994216.

When did PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM receive FDA 510(k) clearance?

PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM received FDA 510(k) clearance on 2000-01-27, under 510(k) number K994216.

Who is the listed applicant for PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM?

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

What is the FDA product code for PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM?

The FDA product code for PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM is LJT.

Related Clinical Trials

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Other records listing Sims Deltec, Inc. as applicant

K010426PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER K000842CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM K000942CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 K992697PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM K992880P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM K991599CADD ADMINISTRATION SET

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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.