FDA 510(k)

STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM

K-Number: K953529 · 1996-01-26

Decision Date1996-01-26

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Strato/Infusaid, Inc.. It received FDA 510(k) clearance on 1996-01-26 under 510(k) number K953529. 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 STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM?

STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-26. The listed applicant is Strato/Infusaid, Inc.. The 510(k) number is K953529.

When did STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM receive FDA 510(k) clearance?

STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM received FDA 510(k) clearance on 1996-01-26, under 510(k) number K953529.

Who is the listed applicant for STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM?

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

What is the FDA product code for STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM?

The FDA product code for STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM 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 Strato/Infusaid, Inc. as applicant

K960391STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771 K954720STRATO/INFUSAIF INFUSE-A-CATH CENTRAL VENOUS CATHETERS K953254STRATO/INFUSAID INFUSE-A-KIT K953436STRATO/INFUSAID INFUSE-A-CATH SINGLE LUMEN SILICONE CENTRAL VENOUS CATHETER SYSTESM K953256STRATO/INFUSAID INFUS-A-CATH DUAL LUMEN PREATTACHED SILICONE CENTRAL VENOUS CATHETER SYSTEMS K950987STRATO/INFUSAID TUNNELER

View all 11 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.