FDA 510(k)

PLASTIC LOW PROFILE SUBCUTANEOUS PORT

K-Number: K924250 · 1993-10-04

Decision Date1993-10-04

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PLASTIC LOW PROFILE SUBCUTANEOUS PORT is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc.. It received FDA 510(k) clearance on 1993-10-04 under 510(k) number K924250. 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 LOW PROFILE SUBCUTANEOUS PORT?

PLASTIC LOW PROFILE SUBCUTANEOUS PORT is a medical device that received FDA 510(k) clearance on 1993-10-04. The listed applicant is Bard Access Systems, Inc.. The 510(k) number is K924250.

When did PLASTIC LOW PROFILE SUBCUTANEOUS PORT receive FDA 510(k) clearance?

PLASTIC LOW PROFILE SUBCUTANEOUS PORT received FDA 510(k) clearance on 1993-10-04, under 510(k) number K924250.

Who is the listed applicant for PLASTIC LOW PROFILE SUBCUTANEOUS PORT?

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

What is the FDA product code for PLASTIC LOW PROFILE SUBCUTANEOUS PORT?

The FDA product code for PLASTIC LOW PROFILE SUBCUTANEOUS PORT is LJT.

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Other records listing Bard Access Systems, Inc. as applicant

K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports K240146BD Prevue™ II Peripheral Vascular Access System K222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly

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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.