FDA.reportPublic FDA data

510(k) K060186

Device
POLYPLEX STIMULATING CATHETER SYSTEM
Applicant
Te ME NA Sas
510(k) number
K060186
Product code
CAZ
Decision
Substantially Equivalent (SESE)
Decision date
2006-07-18
Date received
2006-01-24
Regulation
868.5140
Classification name
Anesthesia Conduction Kit
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
ARTHUR WARD
Address
962 Allegro Ln. Appollo Beach FL US 33572 33572

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CAZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K222341Arrow 0.2 Micron Flat Filter, GVSArrow International, LLC2023-02-13
K210983BD Epilor SyringeBecton, Dickinson and Company2022-05-19
K201356Plastic LOR SyringeJiangsu Caina Medical Co.,Ltd2021-02-12
K202699E-Cath STIM acc. TsuiPAJUNK GmbH Medizintechnologie2020-12-29
K190345VPCPAJUNK GmbH Medizintechnologie2019-05-16
K161075Arrow Epidural Catheter KitTeleflexmedical, Inc.2016-10-04
K153652ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/SetTeleflex, Inc.2016-06-21
K143581Arrow Epidural Catheter KitTeleflexmedical, Inc.2015-06-26
K122690ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLEArrow International, Inc.2012-12-21
K110053CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KITSmiths Medical Asd, Inc.2012-09-14
K122027ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETERArrow International, Inc.2012-08-28
K121525PERIFUSE CATHETERSmiths Medical Asd, Inc.2012-08-02
K121403CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SETTeleflex, Inc.2012-06-20
K103658FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTERTeleflex, Inc.2012-05-16
K113662FENESTRATED NERVE BLOCK NEEDLEImd, Inc.2012-04-20