FDA 510(k)

PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS

K-Number: K093414 · 2010-03-01

Decision Date2010-03-01

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2010-03-01 under 510(k) number K093414. 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 PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS?

PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS is a medical device that received FDA 510(k) clearance on 2010-03-01. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K093414.

When did PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS receive FDA 510(k) clearance?

PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS received FDA 510(k) clearance on 2010-03-01, under 510(k) number K093414.

Who is the listed applicant for PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS?

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

What is the FDA product code for PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS?

The FDA product code for PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS is LJT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Smiths Medical Asd, Inc. as applicant

K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula K211634Hypodermic Needle-Pro EDGE Safety Device K192375Intellifuse Administration and Intellifuse Blood Administration Sets K181699Level 1 Convective Warmer K172800Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors

View all 51 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.