Atlas FDA

STERILE SALINE FOR CATHETER CARE

FDA 510(k) clearance K974397 · decided 1998-02-10

Clearance details

K-number
K974397
Device name
STERILE SALINE FOR CATHETER CARE
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1997-11-21
Decision date
1998-02-10
Days to decision
81 days
Clearance type
Traditional
Product code
JOL
Device class
2
Regulation number
880.6740
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Round Lake, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 (K051370)Baxter Healthcare Corp2005-08-12
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (K000266)Primary Care Solutions, Inc.2001-07-12
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION (K000265)Primary Care Solutions, Inc.2001-07-12
WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION (K003402)Welcon, Inc.2001-05-01
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (K994321)Automatic Liquid Packaging, Inc.2000-10-25
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (K974759)Hydrox Laboratories1998-03-09
HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE (K974758)Hydrox Laboratories1998-03-09
STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (K973734)Welcon, Inc.1998-02-05
GERM TRAPPER SUCTION TUBE HOLDER (K972372)Rzv Medical Specialties, Inc.1997-12-11
CPR SUCTION CATHETER KIT (K960216)Custom Pack Reliability1996-04-15
STERILE ISOTONIC SALINE & STERILE WATER (K954442)Medcare Custom Packaging, Inc.1995-12-21
ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER (K950201)Sherwood Medical Co.1995-12-15

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077)Baxter Healthcare Corp2025-11-13
FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076)Baxter Healthcare Corp2025-06-30
Floseal Hemostatic Matrix (P990009/S075)Baxter Healthcare Corp2025-01-30
Adept Adhesion Reduction Solution (P050011/S009)Baxter Healthcare Corp2024-08-23
Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074)Baxter Healthcare Corp2024-08-15
Floseal Hemostatic Matrix (P990009/S073)Baxter Healthcare Corp2024-01-10
Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072)Baxter Healthcare Corp2023-12-12
Floseal Hemostatic Matrix, RT5 (P990009/S070)Baxter Healthcare Corp2023-02-02