510(k) K022110

Device
KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS.
Applicant
Kawasumi Laboratories, Inc.
510(k) number
K022110
Product code
LJT
Decision
Substantially Equivalent (SESE)
Decision date
2002-09-12
Date received
2002-06-28
Regulation
880.5965
Classification name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
DONALD R STONE
Address
1800 Massachusetts Ave. NW Suite 200 Washington DC US 20036 20036

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LJT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable PortBard Access Systems, Inc.2025-09-05
K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable PortBard Access Systems, Inc.2025-06-18
K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsBard Access Systems, Inc.2024-10-31
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.2023-12-08
K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc.2020-05-22
K181446Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc.2019-07-08
K151239NMI DUAL PORT IINavilyst Medical, Inc.2016-06-06
K153359BardPort®, SlimPort®, and X-Port® Implanted PortsC.R. Bard, Inc.2016-05-20
K153238Dignity Dual PortMedcomp ( Medical Components)2016-03-15
K153228NMI Port, NMI Port IINavilyst Medical, Inc.2015-12-04
K150514Power-Injectable Implantable Ports with ChronoFlex Polyurethane CathetersC.R. Bard, Inc.2015-11-20
K150733Vital-Port Vascular Access System Power Injectable PortCook Incorporated2015-05-21
K141146INVISIPORTStealth Therapeutics, Incorporated2015-05-01
K140169VITAL-PORT(R) CT VASCULAR ACCESS SYSTEMCook Incorporated2014-05-21
K133335POWERPORT IMPLANTABLE PORTC.R. Bard, Inc.2014-02-14