FDA 510(k)

Bard Power-Injectable Implantable Ports (PowerPorts®)

Numéro K : K181446 · 2019-07-08

Date de décision2019-07-08

Code produitLJT

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Bard Power-Injectable Implantable Ports (PowerPorts®) is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2019-07-08 under 510(k) number K181446. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Bard Power-Injectable Implantable Ports (PowerPorts®)?

Bard Power-Injectable Implantable Ports (PowerPorts®) is a medical device that received FDA 510(k) clearance on 2019-07-08. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K181446.

When did Bard Power-Injectable Implantable Ports (PowerPorts®) receive FDA 510(k) clearance?

Bard Power-Injectable Implantable Ports (PowerPorts®) received FDA 510(k) clearance on 2019-07-08, under 510(k) number K181446.

Who is the listed applicant for Bard Power-Injectable Implantable Ports (PowerPorts®)?

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

What is the FDA product code for Bard Power-Injectable Implantable Ports (PowerPorts®)?

The FDA product code for Bard Power-Injectable Implantable Ports (PowerPorts®) is LJT.

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Dispositifs connexes (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.

Source officielle

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