FDA.reportPublic FDA data

510(k) K863247

Device
AXIOM TROCAR THORACIC CATHETER
Applicant
AXIOM MEDICAL, INC.
510(k) number
K863247
Product code
GBS  
Decision
Substantially Equivalent (SESE)
Decision date
1986-08-29
Date received
1986-08-22
Regulation
878.4200
Classification name
Catheter, Ventricular, General & Plastic Surgery
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROGER WOOD
Address
7625 Rosecrans Ave. Suite 29/ P.O. Box 1306 Paramount CA US 90723 90723

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GBS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K912645ATRIUMS PDR THORACIC CATHETERAtrium Medical Corp.1991-09-13
K883887AXIOM ATRAUM WOUND DRAINSAxiom, Inc.1989-02-17
K881873INTRODUCTION/DRAINAGE CATHETER & ACCESSSheridan Catheter Corp.1988-05-18
K880895URESIL WOUND DRAIN TROCARUresil Corp.1988-03-14
K880376NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAPGenesis Industries, Inc.1988-02-16
K873377CLOSED CHEST DRAINAGE SET W/SUTURESGish Biomedical, Inc.1987-10-28
K872460AN3000 MAHONEY DRAINH.W. Andersen Products, Inc.1987-07-23
K872459AN3100 MULHOLLAND DRAINH.W. Andersen Products, Inc.1987-07-21
K872457AN3500 WORTH DRAINH.W. Andersen Products, Inc.1987-07-21
K870015HCI ALL PURPOSE DRAIN/CATHETER SETHealth Care Innovations, Inc.1987-02-06
K863560URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRAUresil Corp.1986-09-29
K863142THORACIC CATHETER (CHEST DRAINAGE TUBE)Sheridan Catheter Corp.1986-08-29
K862584OSTEOTOMY DRAINAGE TUBETreace Medical, Inc.1986-08-12
K862767SILICONE SUMP DRAINSil-Med Corp.1986-08-07
K854418ROUND SUCTION DRAINSil-Med Corp.1985-11-19

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