FDA.reportPublic FDA data

510(k) K874498

Device
CSF-VENTRICULOSTOMY RESERVOIR
Applicant
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
510(k) number
K874498
Product code
LKG  
Decision
Substantially Equivalent (SESE)
Decision date
1988-02-11
Date received
1987-11-02
Regulation
882.5550
Classification name
Port & Catheter, Implanted, Subcutaneous, Intraventricular
Medical specialty
Neurology
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
W LAGUETTE
Address
P.O. Box 2090 Goleta CA US 93118 93118

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LKG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950315CORDIS CSF RESERVOIRCordis Corp.1995-05-09
K881493PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF.Pharmacia Deltec, Inc.1988-05-20
K881690PORT-A-CATH PORTAL INTRODUCER FORCEPSPharmacia Deltec, Inc.1988-05-20
K874468P-S MEDICAL VENTRICULAR ACCESS PORTPudenz-Schulte Medical Research Corp.1988-02-11
K833822P-S MEDICAL CSF ACCESS DEV 15MM/25MMPudenz-Schulte Medical Research Corp.1984-05-25
K833672HH SUBCUTANEOUS ACCESS PORTHolter-Hausner Intl.1984-03-06
K823790VENTRICULAR ACCESS SYSTEMAmerican Heyer Schulte1983-04-28

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases