FDA 510(k)

PORT ACCESS NEEDLE

K-Number: K921902 · 1993-07-28

ApplicantKawasumi Laboratories Co., Ltd.

Decision Date1993-07-28

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PORT ACCESS NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Kawasumi Laboratories Co., Ltd.. It received FDA 510(k) clearance on 1993-07-28 under 510(k) number K921902. 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 ACCESS NEEDLE?

PORT ACCESS NEEDLE is a medical device that received FDA 510(k) clearance on 1993-07-28. The listed applicant is Kawasumi Laboratories Co., Ltd.. The 510(k) number is K921902.

When did PORT ACCESS NEEDLE receive FDA 510(k) clearance?

PORT ACCESS NEEDLE received FDA 510(k) clearance on 1993-07-28, under 510(k) number K921902.

Who is the listed applicant for PORT ACCESS NEEDLE?

The FDA 510(k) record lists Kawasumi Laboratories Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORT ACCESS NEEDLE?

The FDA product code for PORT ACCESS NEEDLE 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 Kawasumi Laboratories Co., Ltd. as applicant

K994323KAWASUMI LABORATORIES PHILEBOTOMY SET K974829NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)K964117NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE K935514VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER K935505WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER K935506MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION

View all 18 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.