FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
FLG
Cleaner, Ultrasonic, Medical Instrument
1
Product Code
FLH
Washer Of Body Waste Receptacles
1
Product Code
FLI
Cabinet, Ethylene-Oxide Gas Aerator
2
Product Code
BRT
Restraint, Patient, Conductive
1
Product Code
BYY
Tube, Aspirating, Flexible, Connecting
2
Product Code
BYZ
Trap, Sterile Specimen
2
Product Code
CBC
Bottle, Collection And Trap, Breathing System (Uncalibrated)
2
Product Code
CBD
Bottle, Collection, Breathing System (Calibrated)
2
Product Code
FLE
Sterilizer, Steam
2
Product Code
FLF
Sterilizer, Ethylene-Oxide Gas
2
Product Code
FMA
Depressor, Tongue, Non-Surgical
1
Product Code
FMC
Patient Examination Glove
1
Product Code
FME
Gown, Examination
1
Product Code
FML
Chair, Blood Donor
1
Product Code
FMP
Protector, Skin Pressure
1
Product Code
FMQ
Restraint, Protective
1
Product Code
FMR
Device, Transfer, Patient, Manual
1
Product Code
FMW
Cover, Mattress (Medical Purposes)
1
Product Code
FNP
Urinal
1
Product Code
FNS
Ring Cutter
1
Product Code
FNY
Basin, Emesis
1
Product Code
FOA
Board, Cardiopulmonary
1
Product Code
FOB
Bedpan
1
Product Code
FOX
Stand, Infusion
1
Product Code
FPF
Bottle, Hot/Cold Water
1
Product Code
FPO
Stretcher, Wheeled
2
Product Code
FPP
Stretcher, Hand-Carried
1
Product Code
FPS
Board, Bed
1
Product Code
FRA
Purifier, Air, Ultraviolet, Medical
2
Product Code
FRG
Wrap, Sterilization
2
Product Code
FRJ
Chair, Geriatric
1
Product Code
FRK
Chair, Examination And Treatment
1
Product Code
FRZ
Device, Patient Transfer, Powered
2
Product Code
GAZ
Tubing, Noninvasive
2
Product Code
GCX
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
2
Product Code
JOK
Scissors, Medical, Disposable
1
Product Code
JOL
Catheter And Tip, Suction
2
Product Code
K
05
1370
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
2
Cleared 510(K)
K
00
0266
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
2
Cleared 510(K)
K
00
0265
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
2
Cleared 510(K)
K
00
3402
WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
2
Cleared 510(K)
K
99
4321
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
2
Cleared 510(K)
K
97
4758
HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
2
Cleared 510(K)
K
97
4759
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
2
Cleared 510(K)
K
97
4397
STERILE SALINE FOR CATHETER CARE
2
Cleared 510(K)
K
97
3734
STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
2
Cleared 510(K)
K
97
2372
GERM TRAPPER SUCTION TUBE HOLDER
2
Cleared 510(K)
K
96
0216
CPR SUCTION CATHETER KIT
2
Cleared 510(K)
K
95
4442
STERILE ISOTONIC SALINE & STERILE WATER
2
Cleared 510(K)
K
95
0201
ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER
2
Cleared 510(K)
K
95
1524
THORACENTESIS CATHETER
2
Cleared 510(K)
K
94
5728
CATCO THORACIC CATHETER
2
Cleared 510(K)
K
94
3661
STERILE PHYSIOLOGICAL SALINE/STERILE WATER
2
Cleared 510(K)
K
94
3773
STERILE WATER
2
Cleared 510(K)
K
94
3836
PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER
2
Cleared 510(K)
K
94
3828
STERILE WATER FOR IRRIGATION
2
Cleared 510(K)
K
94
3829
PRE-FILLED SYSRINGE W/STERILE WATER
2
Cleared 510(K)
K
94
3830
PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION
2
Cleared 510(K)
K
94
3831
PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER
2
Cleared 510(K)
K
94
3832
STERILE .9% SODIUM CHLORIDE FOR IRRATION
2
Cleared 510(K)
K
94
3834
STERILE .9% SODIUM CHLORIDE SOLUTION
2
Cleared 510(K)
K
93
2138
SALINE FOR IRRIGATION
2
Cleared 510(K)
K
94
3833
STERILE WATER FOR IRRATION
2
Cleared 510(K)
K
93
1509
GERITREX STERILE SALINE SOLUTION FOR IRRIGATION
2
Cleared 510(K)
K
93
3762
STB YANKAUER SUCKER/NOZZLE
2
Cleared 510(K)
K
94
2061
DISPOSABLE SUCTION PROBE
2
Cleared 510(K)
K
94
1232
THORA-CATH
2
Cleared 510(K)
K
93
3526
STERILE WATER
2
Cleared 510(K)
K
93
1511
GERITREX STERILE WATER FOR IRRIGATION
2
Cleared 510(K)
K
93
4382
VCI SUCTION/IRRIGATION TUBING SET
2
Cleared 510(K)
K
93
2185
SURGICAL SUCTION TIP
2
Cleared 510(K)
K
92
2714
UNIVERSAL IRRIGATION & SUCTION TUBING SET
2
Cleared 510(K)
K
91
3896
JAIN BLOOD SHIELD
2
Cleared 510(K)
K
91
3876
ENDOTRACHEAL SUCTIONTUBE
2
Cleared 510(K)
K
91
0693
PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET
2
Cleared 510(K)
K
91
0963
THOROCENTESIS KIT
2
Cleared 510(K)
K
90
4216
STERILE WATER SOLUTION CATALOG # 10000
2
Cleared 510(K)
K
90
3569
CURITY THORACENTESIS TRAY
2
Cleared 510(K)
K
89
0039
KLEEN TEST BASIN SET
2
Cleared 510(K)
K
89
3667
SUCTION TIP
2
Cleared 510(K)
K
89
3527
LAPAROSCOPIC SUCTION PROBE
2
Cleared 510(K)
K
89
3135
GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER
2
Cleared 510(K)
K
88
3905
ARROW PNEUMOTHORAX KIT, AK-01500
2
Cleared 510(K)
K
87
2948
URESIL THORA-FLO THORACENTESIS PROCEDURE KIT
2
Cleared 510(K)
K
87
3563
APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY
2
Cleared 510(K)
K
87
3464
VAN DELLEN CANNULA
2
Cleared 510(K)
K
87
3517
DEKNATEL THORACIC CATHETER
2
Cleared 510(K)
K
87
3525
DEKNATEL TROCAR CATHETER
2
Cleared 510(K)
K
87
1950
VIA-GUARD
2
Cleared 510(K)
K
87
0572
ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT
2
Cleared 510(K)
K
86
4937
'EXMOOR' ZOELLNER SUCKER ENDS
2
Cleared 510(K)
K
86
0927
HD CRYSTALINE SUCTION TIP
2
Cleared 510(K)
K
85
2041
DEKNATEL THORACIC CATHETER
2
Cleared 510(K)
K
85
1979
TROCAR CATHETER
2
Cleared 510(K)
K
85
1611
IMPACT TURBO CATH
2
Cleared 510(K)
K
85
1385
THORA-CATH TROCAR-TYPE CHEST DRAINAGE TUBE
2
Cleared 510(K)
K
85
0240
KM PRODUCTS SUCTION TIPS
2
Cleared 510(K)
K
84
3469
PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE-
2
Cleared 510(K)
K
84
3188
WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP
2
Cleared 510(K)
K
84
0669
SUCTION DEVICE-PHARYNEAL DEVICE
2
Cleared 510(K)
K
84
0007
SURGICAL SUCTION INSTRUMENT-REUSABLE
2
Cleared 510(K)
K
83
2880
TRACHEOSTOMY CARE TRAYS
2
Cleared 510(K)
K
83
2517
CUSTOM KWIK SET AND/OR PAK
2
Cleared 510(K)
K
83
1999
FEMORAL CANAL SUCTION TAMPON
2
Cleared 510(K)
K
83
2027
ARGYLE YANKAVER SUCTION TUBE W/CONTROL
2
Cleared 510(K)
K
83
0942
SUCTION CATHETERS
2
Cleared 510(K)
K
82
1342
METAL BACKED ACETABULAR COMPONENT
2
Cleared 510(K)
K
82
0718
ARGYLE THORACIC CATHETERS
2
Cleared 510(K)
K
82
0460
3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION
2
Cleared 510(K)
K
81
2312
STERILE WATER 4OZ.
2
Cleared 510(K)
K
80
3206
SUCTION PROBE
2
Cleared 510(K)
K
80
3187
ARGYLE UNIVERSAL POOLE SUCTION TUBE
2
Cleared 510(K)
K
80
1127
MACROVAC
2
Cleared 510(K)
K
80
1134
MICROVAC
2
Cleared 510(K)
K
80
0635
C.C.-PAK
2
Cleared 510(K)
K
80
0234
ABCO SUCTION CATHETER & KITS W/GLOVE&CUP
2
Cleared 510(K)
K
79
1801
CONPHAR FINGERTIP SUCTION CONTROL
2
Cleared 510(K)
K
78
2027
HYSTERECTOMY T DRAIN
2
Cleared 510(K)
K
77
0983
CATHETER THORACIC, AXIOM
2
Cleared 510(K)
K
77
0233
STERILE SUCTION CATHETER W/CONTROL
2
Cleared 510(K)
K
76
0586
SUCTION KIT
2
Cleared 510(K)
KCT
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
2
Product Code
KDP
Regulator, Vacuum
2
Product Code
KDQ
Bottle, Collection, Vacuum
2
Product Code
KIA
Cover, Cast
1
Product Code
KME
Bedding, Disposable, Medical
1
Product Code
KMG
Purifier, Water, Ultraviolet, Medical
2
Product Code
KMH
Sterilizer, Dry Heat
2
Product Code
KMJ
Lubricant, Patient
1
Product Code
KMN
Chair And Table, Medical
1
Product Code
KXF
Applicator, Absorbent Tipped, Non-Sterile
1
Product Code
KXG
Applicator, Absorbent Tipped, Sterile
1
Product Code
KYR
Bag, Ice
1
Product Code
KYS
Insoles, Medical
1
Product Code
KYT
Light, Examination, Medical, Battery Powered
1
Product Code
KYW
Container, Liquid Medication, Graduated
1
Product Code
KYX
Dispenser, Liquid Medication
1
Product Code
KYZ
Syringe, Irrigating (Non Dental)
1
Product Code
KZA
Device, Vein Location, Liquid Crystal
1
Product Code
KZF
Device, Medical Examination, Ac Powered
1
Product Code
KZH
Introducer, Syringe Needle
2
Product Code
LBJ
Device, Vein Stabilization
1
Product Code
LDS
Device, Pasteurization, Hot Water
2
Product Code
LRJ
Disinfectant, Medical Devices
1
Product Code
LYY
Latex Patient Examination Glove
1
Product Code
LYZ
Vinyl Patient Examination Glove
1
Product Code
LZA
Polymer Patient Examination Glove
1
Product Code
LZB
Finger Cot
1
Product Code
LZC
Patient Examination Glove, Specialty
1
Product Code
MDZ
Cleaners, Medical Devices
2
Product Code
MEC
Disinfector, Medical Devices
2
Product Code
MED
Sterilant, Medical Devices
2
Product Code
MKB
Device, Germicidal, Ultraviolet
2
Product Code
MLR
Sterilizer, Chemical
2
Product Code
MMS
Lubricant, Vaginal, Patient
1
Product Code
MTV
Sharps Needle Destruction Device
2
Product Code
NRV
Implantable Radio Frequency Transponder System
2
Product Code
NZD
Stretcher, Patient Restraint
1
Product Code
NZH
Medication Management System, Remote
2
Product Code
NZJ
Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
2
Product Code
OHY
Pill Crusher/Cutter
1
Product Code
OIG
Powder-Free Guayle Rubber Examination Glove
1
Product Code
PEQ
Accessories To Examination Light
1
Product Code
OPC
Powder-Free Polychloroprene Patient Examination Glove
1
Product Code
OPH
Radiation Attenuating Medical Glove
1
Product Code
OPI
Antimicrobial Medical Glove
1
Product Code
OPJ
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
1
Product Code
ORW
N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies
2
Product Code
OSZ
Antimicrobial Keyboard
2
Product Code
OUG
Medical Device Data System
1
Product Code
OVY
Liquid Chemical Processing System
2
Product Code
OYS
Patient Bed With Canopy/Restraints
1
Product Code
PAD
Chest Drainage Kit
2
Product Code
PEC
Sterilizer Automated Loading System
2
Product Code
PJJ
Two Or More Sterilant Sterilizer
2
Product Code
PWM
Admission Kit (Patient Utensil)
1
Product Code
PYQ
Rfid Chip For Dental Appliance
2
Product Code
PWP
Blood Borne Pathogen Response Kit
1
Product Code
PWS
Chemotherapy Administration Kit
1
Product Code
PWT
Chemotherapy Spill Clean-Up Kit
1
Product Code
PWU
Clean-Up Kit
1
Product Code
PWV
Delivery Room Apparel Kit
1
Product Code
PWZ
Mid-Stream Collection Kit
1
Product Code
PXA
Oral Administration Set
1
Product Code
PXC
Personal Protection Kit
1
Product Code
PXD
Prep Kit
1
Product Code
PXF
Sitz Bath Kit
1
Product Code
PXG
Spill Kit
1
Product Code
PXM
Vomitus Clean-Up Kit
1
Product Code
QDO
Fentanyl And Other Opioid Protection Glove
1
Product Code
QTV
Mattress And Bed Deck Cover (Medical Purposes)
1
Product Code
Subpart G—Miscellaneous Devices
CFR Sub-Part
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 23 May 2025 at 11:06 pm
HO
/
subpart-g—general-hospital-and-personal-use-miscellaneous-devices
/
JOL
/
K873517
View Source
DEKNATEL THORACIC CATHETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K873517
510(k) Type
Traditional
Applicant
DEKNATEL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/2/1987
Days to Decision
62 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Pathology Instrumentation and Accessories
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
FLG
Cleaner, Ultrasonic, Medical Instrument
FLH
Washer Of Body Waste Receptacles
FLI
Cabinet, Ethylene-Oxide Gas Aerator
BRT
Restraint, Patient, Conductive
BYY
Tube, Aspirating, Flexible, Connecting
BYZ
Trap, Sterile Specimen
CBC
Bottle, Collection And Trap, Breathing System (Uncalibrated)
CBD
Bottle, Collection, Breathing System (Calibrated)
FLE
Sterilizer, Steam
FLF
Sterilizer, Ethylene-Oxide Gas
FMA
Depressor, Tongue, Non-Surgical
FMC
Patient Examination Glove
FME
Gown, Examination
FML
Chair, Blood Donor
FMP
Protector, Skin Pressure
FMQ
Restraint, Protective
FMR
Device, Transfer, Patient, Manual
FMW
Cover, Mattress (Medical Purposes)
FNP
Urinal
FNS
Ring Cutter
FNY
Basin, Emesis
FOA
Board, Cardiopulmonary
FOB
Bedpan
FOX
Stand, Infusion
FPF
Bottle, Hot/Cold Water
FPO
Stretcher, Wheeled
FPP
Stretcher, Hand-Carried
FPS
Board, Bed
FRA
Purifier, Air, Ultraviolet, Medical
FRG
Wrap, Sterilization
FRJ
Chair, Geriatric
FRK
Chair, Examination And Treatment
FRZ
Device, Patient Transfer, Powered
GAZ
Tubing, Noninvasive
GCX
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
JOK
Scissors, Medical, Disposable
JOL
Catheter And Tip, Suction
K
05
1370
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
K
00
0266
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
K
00
0265
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
K
00
3402
WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
K
99
4321
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
K
97
4758
HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
K
97
4759
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
K
97
4397
STERILE SALINE FOR CATHETER CARE
K
97
3734
STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
K
97
2372
GERM TRAPPER SUCTION TUBE HOLDER
K
96
0216
CPR SUCTION CATHETER KIT
K
95
4442
STERILE ISOTONIC SALINE & STERILE WATER
K
95
0201
ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER
K
95
1524
THORACENTESIS CATHETER
K
94
5728
CATCO THORACIC CATHETER
K
94
3661
STERILE PHYSIOLOGICAL SALINE/STERILE WATER
K
94
3773
STERILE WATER
K
94
3836
PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER
K
94
3828
STERILE WATER FOR IRRIGATION
K
94
3829
PRE-FILLED SYSRINGE W/STERILE WATER
K
94
3830
PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION
K
94
3831
PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER
K
94
3832
STERILE .9% SODIUM CHLORIDE FOR IRRATION
K
94
3834
STERILE .9% SODIUM CHLORIDE SOLUTION
K
93
2138
SALINE FOR IRRIGATION
K
94
3833
STERILE WATER FOR IRRATION
K
93
1509
GERITREX STERILE SALINE SOLUTION FOR IRRIGATION
K
93
3762
STB YANKAUER SUCKER/NOZZLE
K
94
2061
DISPOSABLE SUCTION PROBE
K
94
1232
THORA-CATH
K
93
3526
STERILE WATER
K
93
1511
GERITREX STERILE WATER FOR IRRIGATION
K
93
4382
VCI SUCTION/IRRIGATION TUBING SET
K
93
2185
SURGICAL SUCTION TIP
K
92
2714
UNIVERSAL IRRIGATION & SUCTION TUBING SET
K
91
3896
JAIN BLOOD SHIELD
K
91
3876
ENDOTRACHEAL SUCTIONTUBE
K
91
0693
PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET
K
91
0963
THOROCENTESIS KIT
K
90
4216
STERILE WATER SOLUTION CATALOG # 10000
K
90
3569
CURITY THORACENTESIS TRAY
K
89
0039
KLEEN TEST BASIN SET
K
89
3667
SUCTION TIP
K
89
3527
LAPAROSCOPIC SUCTION PROBE
K
89
3135
GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER
K
88
3905
ARROW PNEUMOTHORAX KIT, AK-01500
K
87
2948
URESIL THORA-FLO THORACENTESIS PROCEDURE KIT
K
87
3563
APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY
K
87
3464
VAN DELLEN CANNULA
K
87
3517
DEKNATEL THORACIC CATHETER
K
87
3525
DEKNATEL TROCAR CATHETER
K
87
1950
VIA-GUARD
K
87
0572
ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT
K
86
4937
'EXMOOR' ZOELLNER SUCKER ENDS
K
86
0927
HD CRYSTALINE SUCTION TIP
K
85
2041
DEKNATEL THORACIC CATHETER
K
85
1979
TROCAR CATHETER
K
85
1611
IMPACT TURBO CATH
K
85
1385
THORA-CATH TROCAR-TYPE CHEST DRAINAGE TUBE
K
85
0240
KM PRODUCTS SUCTION TIPS
K
84
3469
PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE-
K
84
3188
WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP
K
84
0669
SUCTION DEVICE-PHARYNEAL DEVICE
K
84
0007
SURGICAL SUCTION INSTRUMENT-REUSABLE
K
83
2880
TRACHEOSTOMY CARE TRAYS
K
83
2517
CUSTOM KWIK SET AND/OR PAK
K
83
1999
FEMORAL CANAL SUCTION TAMPON
K
83
2027
ARGYLE YANKAVER SUCTION TUBE W/CONTROL
K
83
0942
SUCTION CATHETERS
K
82
1342
METAL BACKED ACETABULAR COMPONENT
K
82
0718
ARGYLE THORACIC CATHETERS
K
82
0460
3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION
K
81
2312
STERILE WATER 4OZ.
K
80
3206
SUCTION PROBE
K
80
3187
ARGYLE UNIVERSAL POOLE SUCTION TUBE
K
80
1127
MACROVAC
K
80
1134
MICROVAC
K
80
0635
C.C.-PAK
K
80
0234
ABCO SUCTION CATHETER & KITS W/GLOVE&CUP
K
79
1801
CONPHAR FINGERTIP SUCTION CONTROL
K
78
2027
HYSTERECTOMY T DRAIN
K
77
0983
CATHETER THORACIC, AXIOM
K
77
0233
STERILE SUCTION CATHETER W/CONTROL
K
76
0586
SUCTION KIT
KCT
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
KDP
Regulator, Vacuum
KDQ
Bottle, Collection, Vacuum
KIA
Cover, Cast
KME
Bedding, Disposable, Medical
KMG
Purifier, Water, Ultraviolet, Medical
KMH
Sterilizer, Dry Heat
KMJ
Lubricant, Patient
KMN
Chair And Table, Medical
KXF
Applicator, Absorbent Tipped, Non-Sterile
KXG
Applicator, Absorbent Tipped, Sterile
KYR
Bag, Ice
KYS
Insoles, Medical
KYT
Light, Examination, Medical, Battery Powered
KYW
Container, Liquid Medication, Graduated
KYX
Dispenser, Liquid Medication
KYZ
Syringe, Irrigating (Non Dental)
KZA
Device, Vein Location, Liquid Crystal
KZF
Device, Medical Examination, Ac Powered
KZH
Introducer, Syringe Needle
LBJ
Device, Vein Stabilization
LDS
Device, Pasteurization, Hot Water
LRJ
Disinfectant, Medical Devices
LYY
Latex Patient Examination Glove
LYZ
Vinyl Patient Examination Glove
LZA
Polymer Patient Examination Glove
LZB
Finger Cot
LZC
Patient Examination Glove, Specialty
MDZ
Cleaners, Medical Devices
MEC
Disinfector, Medical Devices
MED
Sterilant, Medical Devices
MKB
Device, Germicidal, Ultraviolet
MLR
Sterilizer, Chemical
MMS
Lubricant, Vaginal, Patient
MTV
Sharps Needle Destruction Device
NRV
Implantable Radio Frequency Transponder System
NZD
Stretcher, Patient Restraint
NZH
Medication Management System, Remote
NZJ
Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
OHY
Pill Crusher/Cutter
OIG
Powder-Free Guayle Rubber Examination Glove
PEQ
Accessories To Examination Light
OPC
Powder-Free Polychloroprene Patient Examination Glove
OPH
Radiation Attenuating Medical Glove
OPI
Antimicrobial Medical Glove
OPJ
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
ORW
N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies
OSZ
Antimicrobial Keyboard
OUG
Medical Device Data System
OVY
Liquid Chemical Processing System
OYS
Patient Bed With Canopy/Restraints
PAD
Chest Drainage Kit
PEC
Sterilizer Automated Loading System
PJJ
Two Or More Sterilant Sterilizer
PWM
Admission Kit (Patient Utensil)
PYQ
Rfid Chip For Dental Appliance
PWP
Blood Borne Pathogen Response Kit
PWS
Chemotherapy Administration Kit
PWT
Chemotherapy Spill Clean-Up Kit
PWU
Clean-Up Kit
PWV
Delivery Room Apparel Kit
PWZ
Mid-Stream Collection Kit
PXA
Oral Administration Set
PXC
Personal Protection Kit
PXD
Prep Kit
PXF
Sitz Bath Kit
PXG
Spill Kit
PXM
Vomitus Clean-Up Kit
QDO
Fentanyl And Other Opioid Protection Glove
QTV
Mattress And Bed Deck Cover (Medical Purposes)
Subpart G—Miscellaneous Devices
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
HO
/
subpart-g—general-hospital-and-personal-use-miscellaneous-devices
/
JOL
/
K873517
View Source
DEKNATEL THORACIC CATHETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K873517
510(k) Type
Traditional
Applicant
DEKNATEL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/2/1987
Days to Decision
62 days