FDA.report

510(k) K051370

Device
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
Applicant
Baxter Healthcare Corp
510(k) number
K051370
Product code
JOL
Decision
Substantially Equivalent (SESE)
Decision date
2005-08-12
Date received
2005-05-26
Regulation
880.6740
Classification name
Catheter And Tip, Suction
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
NANETTE HEDDEN
Address
1620 Waukegan Rd., Mpgr-Al Mcgaw Park IL US 60085 60085

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code JOL

510(k)DeviceApplicantDecision date
K000266PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATIONPrimary Care Solutions, Inc.2001-07-12
K000265PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATIONPrimary Care Solutions, Inc.2001-07-12
K003402WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATIONWelcon, Inc.2001-05-01
K994321STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USPAutomatic Liquid Packaging, Inc.2000-10-25
K974759HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLEHydrox Laboratories1998-03-09
K974758HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLEHydrox Laboratories1998-03-09
K974397STERILE SALINE FOR CATHETER CAREBaxter Healthcare Corp1998-02-10
K973734STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATIONWelcon, Inc.1998-02-05
K972372GERM TRAPPER SUCTION TUBE HOLDERRzv Medical Specialties, Inc.1997-12-11
K960216CPR SUCTION CATHETER KITCustom Pack Reliability1996-04-15
K954442STERILE ISOTONIC SALINE & STERILE WATERMedcare Custom Packaging, Inc.1995-12-21
K950201ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETERSherwood Medical Co.1995-12-15
K951524THORACENTESIS CATHETERBaxter Healthcare Corp1995-07-06
K945728CATCO THORACIC CATHETERCatco Medical, Inc.1995-05-23
K943661STERILE PHYSIOLOGICAL SALINE/STERILE WATERMedcare Custom Packaging, Inc.1995-04-10