FDA 510(k)

CELSITE IMPLANTABLE ACCESS PORT SYSTEMS

K-Number: K130576 · 2013-04-02

ApplicantB. Braun Interventional Systems, Inc.

Decision Date2013-04-02

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

CELSITE IMPLANTABLE ACCESS PORT SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is B. Braun Interventional Systems, Inc.. It received FDA 510(k) clearance on 2013-04-02 under 510(k) number K130576. 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 CELSITE IMPLANTABLE ACCESS PORT SYSTEMS?

CELSITE IMPLANTABLE ACCESS PORT SYSTEMS is a medical device that received FDA 510(k) clearance on 2013-04-02. The listed applicant is B. Braun Interventional Systems, Inc.. The 510(k) number is K130576.

When did CELSITE IMPLANTABLE ACCESS PORT SYSTEMS receive FDA 510(k) clearance?

CELSITE IMPLANTABLE ACCESS PORT SYSTEMS received FDA 510(k) clearance on 2013-04-02, under 510(k) number K130576.

Who is the listed applicant for CELSITE IMPLANTABLE ACCESS PORT SYSTEMS?

The FDA 510(k) record lists B. Braun Interventional Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CELSITE IMPLANTABLE ACCESS PORT SYSTEMS?

The FDA product code for CELSITE IMPLANTABLE ACCESS PORT SYSTEMS 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.