FDA Browser
by
Innolitics
Anesthesiology
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—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular 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—Miscellaneous
CFR Sub-Part
BRX
Stool, Anesthesia
1
Product Code
BRY
Cabinet, Table And Tray, Anesthesia
1
Product Code
BSY
Catheters, Suction, Tracheobronchial
1
Product Code
K
03
1997
MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM
1
Cleared 510(K)
K
99
2902
AMBU HAND POWER SUCTION PUMP
1
Cleared 510(K)
K
98
2945
DUAL PURPOSE CLOSED CATHETER
1
Cleared 510(K)
K
98
1910
SUCTION CATHETER
1
Cleared 510(K)
K
97
2258
HI-CARE CLOSED SUCTION SYSTEM
1
Cleared 510(K)
K
97
3199
AMSINO SUCTION CATHETER
1
Cleared 510(K)
K
96
1707
TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM
1
Cleared 510(K)
K
96
4369
TRACH CARE SET WITH MICROBAN
1
Cleared 510(K)
K
96
0488
NEO 2 LINE SUCTION SYSTEM
1
Cleared 510(K)
K
95
5831
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
1
Cleared 510(K)
K
95
5645
CATH-GUIDE
1
Cleared 510(K)
K
95
2396
REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION
1
Cleared 510(K)
K
95
2395
REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION
1
Cleared 510(K)
K
95
3226
PULM O2 SUCTION CATHETER TRAYS
1
Cleared 510(K)
K
95
1506
SUCTION CATHETER KIT, STERILE, SINGLE-USE
1
Cleared 510(K)
K
94
5994
DUAL PURPOSE CATHETER
1
Cleared 510(K)
K
95
1745
CONNECTING TUBE
1
Cleared 510(K)
K
94
5950
TRIGUARD(TM) SUCTION SYSTEM
1
Cleared 510(K)
K
94
4251
KENDALL MODU-VAC CLOSED SUCTION SYSTEM
1
Cleared 510(K)
K
93
5600
TRACHEAL SUCTION CATHETER
1
Cleared 510(K)
K
93
5583
SUCTION SET, TRACHAEL
1
Cleared 510(K)
K
93
5553
MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP
1
Cleared 510(K)
K
93
4723
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
1
Cleared 510(K)
K
92
5556
ARGYLE ASPIR-FLEX SUCTION CATHETER
1
Cleared 510(K)
K
92
1851
4 SURE TM SUCTION CATHETERS & KITS
1
Cleared 510(K)
K
92
2843
DYNAREX SUCTION CATHETERS & KITS
1
Cleared 510(K)
K
92
2148
ARGYLE AERO-JET SUCTION CATHETER
1
Cleared 510(K)
K
92
3098
STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE
1
Cleared 510(K)
K
90
3480
HANN-VAC TM, DISPOSABLE,SUCTION CATHETER
1
Cleared 510(K)
K
91
2596
MECONIUM ASPIRATION
1
Cleared 510(K)
K
91
0239
NEBU-SOL METERED DOSE DISPENSER (TM)
1
Cleared 510(K)
K
91
0909
MUCAID
1
Cleared 510(K)
K
91
0908
MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING
1
Cleared 510(K)
K
90
3552
ORAL-CATH SUCTION CATHETER
1
Cleared 510(K)
K
90
3740
TRACH-EZE
1
Cleared 510(K)
K
90
2093
RESU-GARD CATHETER SUCTION
1
Cleared 510(K)
K
90
3669
GENESIS INSUFFLATING CATHETER
1
Cleared 510(K)
K
90
2687
STERI-CATH-DL
1
Cleared 510(K)
K
90
2814
SUCTION CATHETER, STERILE
1
Cleared 510(K)
K
90
2297
BUSSE BAC/SHIELD
1
Cleared 510(K)
K
90
2383
STERI-CATH(TM)
1
Cleared 510(K)
K
89
6887
TRACHAEL SUCTION SET
1
Cleared 510(K)
K
89
6730
SUCTION CATHETER STRAIGHT/COUDE
1
Cleared 510(K)
K
89
6797
SUCTION CATHETER KIT
1
Cleared 510(K)
K
89
6560
MUCOUS TRAP
1
Cleared 510(K)
K
89
6321
NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.
1
Cleared 510(K)
K
89
4299
REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM
1
Cleared 510(K)
K
89
2529
REPRO-MED NEONATE ASPIRATION SYSTEM
1
Cleared 510(K)
K
89
3462
NU-TRAP SUCTION CATHETER W/MUCUS TRAP
1
Cleared 510(K)
K
89
3204
MUC-X
1
Cleared 510(K)
K
89
2441
KENDALL CURITY SUCTION CATHETERS
1
Cleared 510(K)
K
89
2343
SUCTION CONTROL VALVE
1
Cleared 510(K)
K
89
0425
NEOTECH MUCUS TRAP W/CATHETER
1
Cleared 510(K)
K
88
4944
TU SUCTIONTRAP
1
Cleared 510(K)
K
88
5131
KIT PAK SUCTION CATHETER KIT
1
Cleared 510(K)
K
88
3384
TS1000 SUCTION TIP
1
Cleared 510(K)
K
88
2017
RESPIRONICS SUCTIONEASY
1
Cleared 510(K)
K
88
1428
OXY-CATH
1
Cleared 510(K)
K
87
5058
STERILE MUCUS SPECIMEN TRAP, MODELS 406 & 407
1
Cleared 510(K)
K
87
3810
SAFETY SHIELD SUCTION CATHETER
1
Cleared 510(K)
K
87
3610
PEDIATRIC BUBBLE TRAP CAT. NO. B-100
1
Cleared 510(K)
K
87
3732
TRACH CARE START KIT
1
Cleared 510(K)
K
87
2621
TRACH CARE CATHETER
1
Cleared 510(K)
K
87
2141
CENTURION SPECIMEN TRAP W/CATHETER
1
Cleared 510(K)
K
87
2917
JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER
1
Cleared 510(K)
K
87
2283
ORAL SUCTION CATHETER
1
Cleared 510(K)
K
87
1825
MECONIUM SUCTION CATHETER
1
Cleared 510(K)
K
87
1949
MMG DELEE SUCTION CATHETER W/MUCOUS TRAP
1
Cleared 510(K)
K
87
1407
MECONIUM ASPIRATOR
1
Cleared 510(K)
K
87
0962
GESCO ASPIRATOR
1
Cleared 510(K)
K
86
4535
TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110
1
Cleared 510(K)
K
86
4468
TRACHEOBRONCHIAL SUCTION CATHETER
1
Cleared 510(K)
K
86
1949
SUCTION CATHETER KIT
1
Cleared 510(K)
K
86
3497
SUCTION CATHETER KIT
1
Cleared 510(K)
K
86
2181
MECONIUM SUCTION TRAP
1
Cleared 510(K)
K
86
2132
HCI MECONIUM ASPIRATOR
1
Cleared 510(K)
K
86
0802
TRACHEOBRONCHIAL SUCTION CATHETER
1
Cleared 510(K)
K
85
4320
ACKRAD ORAL SUCTION TUBE
1
Cleared 510(K)
K
85
1473
VYGON DELEE SUCTION CATHETER CODE NO 533
1
Cleared 510(K)
K
85
2080
PENNINE SUCTION CATHETERS
1
Cleared 510(K)
K
85
2079
PENNINE DERBY YANKAUER
1
Cleared 510(K)
K
85
0864
TRACHEOBRONCHIAL SUCTION KITS W/CATHETERS ETO
1
Cleared 510(K)
K
85
0784
BRONCHITRAC L
1
Cleared 510(K)
K
85
0105
KM PRODUCTS ASPIRATING TUBING
1
Cleared 510(K)
K
84
2166
INTERMED, INS STERILE WATER/SALINE
1
Cleared 510(K)
K
85
0032
A FAMILY OF TRACHEOBRONCHIAL SUCTION CATHETER PROD
1
Cleared 510(K)
K
84
3797
STERILE SALINE SOLUTION
1
Cleared 510(K)
K
84
3076
SUCTION CATHETER KIT
1
Cleared 510(K)
K
84
2779
ACT, SUCTION TIP
1
Cleared 510(K)
K
84
1425
JINOTTI OXYGEN/SUCTION CATHETER
1
Cleared 510(K)
K
84
2198
AMER. PHARMASEAL NO TOUCH SATIN CATHET
1
Cleared 510(K)
K
84
2205
OXY-VAC
1
Cleared 510(K)
K
84
1480
INFECTION CONTROL VALVE
1
Cleared 510(K)
K
84
0664
TRACHEOSTOMY CLEANING TRAY
1
Cleared 510(K)
K
83
3375
DUAL PURPOSE CATHETER
1
Cleared 510(K)
K
83
3908
IRRI-CATH
1
Cleared 510(K)
K
83
3633
BRONCHITRAC DF DUAL RESP/CATHETER
1
Cleared 510(K)
K
83
0709
ARGYLE SUCTION CATHETERS
1
Cleared 510(K)
K
82
2724
SUCTION TUBES
1
Cleared 510(K)
K
82
2398
ACKRAD BRONCHITRAC
1
Cleared 510(K)
K
82
0369
SUCTION CATHETERS & KITS
1
Cleared 510(K)
K
82
0109
RADIATION STERILIZED SUCTION CATHETERS
1
Cleared 510(K)
K
81
3324
BODAI SWIVEL Y
1
Cleared 510(K)
K
81
3163
SUCTION CATHETER
1
Cleared 510(K)
K
81
3209
TRACHEOBRONCHIAL SUCTION CATHETER
1
Cleared 510(K)
K
81
2747
ARGYLE SUCTION CATHETERS
1
Cleared 510(K)
K
81
1542
MGN SUCTION CATHETER
1
Cleared 510(K)
K
81
1241
BODAI SUCTION -SAFE 4
1
Cleared 510(K)
K
81
0023
HYDROPHILIC COATED CATHETER
1
Cleared 510(K)
K
80
1814
CATHETER SUCTION TRACHEOBRONCHIAL
1
Cleared 510(K)
K
80
1551
ARGYLE SAF-T-MARK SUCTION CATHETER
1
Cleared 510(K)
K
80
0503
SUCTION CATHETER
1
Cleared 510(K)
K
79
1253
CONPHAR SUCTION CATHETER-W/0 CONTROL
1
Cleared 510(K)
K
79
0606
CATHETERS, GREENLINE SUCTION
1
Cleared 510(K)
K
76
0427
CATHETER, DOVER SUCTION W/ GLOVE
1
Cleared 510(K)
K
76
0371
VENT-O2-CATH
1
Cleared 510(K)
BTI
Compressor, Air, Portable
2
Product Code
BXJ
Clip, Nose
1
Product Code
BXK
Gas, Calibration (Specified Concentration)
1
Product Code
BZN
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
1
Product Code
CAM
Yoke Assembly, Medical Gas
1
Product Code
CCX
Support, Patient Position
1
Product Code
OFO
Airway Suction Kit
1
Product Code
OFR
Tracheobronchial Suction Catheter Kit
1
Product Code
OFS
Tracheal Suction Set
1
Product Code
OYI
Non-Bronchoscopic Bronchoalveolar Lavage Catheter
1
Product Code
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
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 16 August 2024 at 11:05 pm
AN
/
subpart-g—miscellaneous
/
BSY
/
K922148
View Source
ARGYLE AERO-JET SUCTION CATHETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K922148
510(k) Type
Traditional
Applicant
SHERWOOD MEDICAL CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/7/1992
Days to Decision
214 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous
BRX
Stool, Anesthesia
BRY
Cabinet, Table And Tray, Anesthesia
BSY
Catheters, Suction, Tracheobronchial
K
03
1997
MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM
K
99
2902
AMBU HAND POWER SUCTION PUMP
K
98
2945
DUAL PURPOSE CLOSED CATHETER
K
98
1910
SUCTION CATHETER
K
97
2258
HI-CARE CLOSED SUCTION SYSTEM
K
97
3199
AMSINO SUCTION CATHETER
K
96
1707
TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM
K
96
4369
TRACH CARE SET WITH MICROBAN
K
96
0488
NEO 2 LINE SUCTION SYSTEM
K
95
5831
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
K
95
5645
CATH-GUIDE
K
95
2396
REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION
K
95
2395
REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION
K
95
3226
PULM O2 SUCTION CATHETER TRAYS
K
95
1506
SUCTION CATHETER KIT, STERILE, SINGLE-USE
K
94
5994
DUAL PURPOSE CATHETER
K
95
1745
CONNECTING TUBE
K
94
5950
TRIGUARD(TM) SUCTION SYSTEM
K
94
4251
KENDALL MODU-VAC CLOSED SUCTION SYSTEM
K
93
5600
TRACHEAL SUCTION CATHETER
K
93
5583
SUCTION SET, TRACHAEL
K
93
5553
MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP
K
93
4723
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
K
92
5556
ARGYLE ASPIR-FLEX SUCTION CATHETER
K
92
1851
4 SURE TM SUCTION CATHETERS & KITS
K
92
2843
DYNAREX SUCTION CATHETERS & KITS
K
92
2148
ARGYLE AERO-JET SUCTION CATHETER
K
92
3098
STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE
K
90
3480
HANN-VAC TM, DISPOSABLE,SUCTION CATHETER
K
91
2596
MECONIUM ASPIRATION
K
91
0239
NEBU-SOL METERED DOSE DISPENSER (TM)
K
91
0909
MUCAID
K
91
0908
MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING
K
90
3552
ORAL-CATH SUCTION CATHETER
K
90
3740
TRACH-EZE
K
90
2093
RESU-GARD CATHETER SUCTION
K
90
3669
GENESIS INSUFFLATING CATHETER
K
90
2687
STERI-CATH-DL
K
90
2814
SUCTION CATHETER, STERILE
K
90
2297
BUSSE BAC/SHIELD
K
90
2383
STERI-CATH(TM)
K
89
6887
TRACHAEL SUCTION SET
K
89
6730
SUCTION CATHETER STRAIGHT/COUDE
K
89
6797
SUCTION CATHETER KIT
K
89
6560
MUCOUS TRAP
K
89
6321
NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.
K
89
4299
REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM
K
89
2529
REPRO-MED NEONATE ASPIRATION SYSTEM
K
89
3462
NU-TRAP SUCTION CATHETER W/MUCUS TRAP
K
89
3204
MUC-X
K
89
2441
KENDALL CURITY SUCTION CATHETERS
K
89
2343
SUCTION CONTROL VALVE
K
89
0425
NEOTECH MUCUS TRAP W/CATHETER
K
88
4944
TU SUCTIONTRAP
K
88
5131
KIT PAK SUCTION CATHETER KIT
K
88
3384
TS1000 SUCTION TIP
K
88
2017
RESPIRONICS SUCTIONEASY
K
88
1428
OXY-CATH
K
87
5058
STERILE MUCUS SPECIMEN TRAP, MODELS 406 & 407
K
87
3810
SAFETY SHIELD SUCTION CATHETER
K
87
3610
PEDIATRIC BUBBLE TRAP CAT. NO. B-100
K
87
3732
TRACH CARE START KIT
K
87
2621
TRACH CARE CATHETER
K
87
2141
CENTURION SPECIMEN TRAP W/CATHETER
K
87
2917
JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER
K
87
2283
ORAL SUCTION CATHETER
K
87
1825
MECONIUM SUCTION CATHETER
K
87
1949
MMG DELEE SUCTION CATHETER W/MUCOUS TRAP
K
87
1407
MECONIUM ASPIRATOR
K
87
0962
GESCO ASPIRATOR
K
86
4535
TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110
K
86
4468
TRACHEOBRONCHIAL SUCTION CATHETER
K
86
1949
SUCTION CATHETER KIT
K
86
3497
SUCTION CATHETER KIT
K
86
2181
MECONIUM SUCTION TRAP
K
86
2132
HCI MECONIUM ASPIRATOR
K
86
0802
TRACHEOBRONCHIAL SUCTION CATHETER
K
85
4320
ACKRAD ORAL SUCTION TUBE
K
85
1473
VYGON DELEE SUCTION CATHETER CODE NO 533
K
85
2080
PENNINE SUCTION CATHETERS
K
85
2079
PENNINE DERBY YANKAUER
K
85
0864
TRACHEOBRONCHIAL SUCTION KITS W/CATHETERS ETO
K
85
0784
BRONCHITRAC L
K
85
0105
KM PRODUCTS ASPIRATING TUBING
K
84
2166
INTERMED, INS STERILE WATER/SALINE
K
85
0032
A FAMILY OF TRACHEOBRONCHIAL SUCTION CATHETER PROD
K
84
3797
STERILE SALINE SOLUTION
K
84
3076
SUCTION CATHETER KIT
K
84
2779
ACT, SUCTION TIP
K
84
1425
JINOTTI OXYGEN/SUCTION CATHETER
K
84
2198
AMER. PHARMASEAL NO TOUCH SATIN CATHET
K
84
2205
OXY-VAC
K
84
1480
INFECTION CONTROL VALVE
K
84
0664
TRACHEOSTOMY CLEANING TRAY
K
83
3375
DUAL PURPOSE CATHETER
K
83
3908
IRRI-CATH
K
83
3633
BRONCHITRAC DF DUAL RESP/CATHETER
K
83
0709
ARGYLE SUCTION CATHETERS
K
82
2724
SUCTION TUBES
K
82
2398
ACKRAD BRONCHITRAC
K
82
0369
SUCTION CATHETERS & KITS
K
82
0109
RADIATION STERILIZED SUCTION CATHETERS
K
81
3324
BODAI SWIVEL Y
K
81
3163
SUCTION CATHETER
K
81
3209
TRACHEOBRONCHIAL SUCTION CATHETER
K
81
2747
ARGYLE SUCTION CATHETERS
K
81
1542
MGN SUCTION CATHETER
K
81
1241
BODAI SUCTION -SAFE 4
K
81
0023
HYDROPHILIC COATED CATHETER
K
80
1814
CATHETER SUCTION TRACHEOBRONCHIAL
K
80
1551
ARGYLE SAF-T-MARK SUCTION CATHETER
K
80
0503
SUCTION CATHETER
K
79
1253
CONPHAR SUCTION CATHETER-W/0 CONTROL
K
79
0606
CATHETERS, GREENLINE SUCTION
K
76
0427
CATHETER, DOVER SUCTION W/ GLOVE
K
76
0371
VENT-O2-CATH
BTI
Compressor, Air, Portable
BXJ
Clip, Nose
BXK
Gas, Calibration (Specified Concentration)
BZN
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
CAM
Yoke Assembly, Medical Gas
CCX
Support, Patient Position
OFO
Airway Suction Kit
OFR
Tracheobronchial Suction Catheter Kit
OFS
Tracheal Suction Set
OYI
Non-Bronchoscopic Bronchoalveolar Lavage Catheter
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
subpart-g—miscellaneous
/
BSY
/
K922148
View Source
ARGYLE AERO-JET SUCTION CATHETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K922148
510(k) Type
Traditional
Applicant
SHERWOOD MEDICAL CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/7/1992
Days to Decision
214 days
Submission Type
Statement