FDA.reportPublic FDA data

510(k) K833908

Device
IRRI-CATH
Applicant
PORTEX, INC.
510(k) number
K833908
Product code
BSY  
Decision
Substantially Equivalent (SESE)
Decision date
1984-02-04
Date received
1983-11-14
Regulation
868.6810
Classification name
Catheters, Suction, Tracheobronchial
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BSY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.2003-11-25
K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.1999-10-25
K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.1998-09-22
K981910SUCTION CATHETERNi-Med, Inc.1998-08-24
K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt Medical1997-12-29
K973199AMSINO SUCTION CATHETERAmsino Intl., Inc.1997-09-10
K961707TRACH-EZE CLOSED VENTILATION SUCTION SYSTEMSorenson Critical Care1997-03-11
K964369TRACH CARE SET WITH MICROBANBallard Medical Products1997-02-11
K960488NEO 2 LINE SUCTION SYSTEMAlcove Medical, Inc.1996-04-26
K955831ARGYLE ASPR-CARE CLOSED SUCTION SYSTEMSherwood Medical Co.1996-03-28
K955645CATH-GUIDEHudson Respiratory Care, Inc.1996-03-12
K952396REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTIONContour Fabricators of Florida, Inc.1995-08-15
K952395REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATIONContour Fabricators of Florida, Inc.1995-08-15
K953226PULM O2 SUCTION CATHETER TRAYSPremium Plastics, Inc.1995-08-08
K951506SUCTION CATHETER KIT, STERILE, SINGLE-USETrinity Laboratories, Inc.1995-07-03

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