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Innolitics
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Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
FPX
Strip, Adhesive, Closure, Skin
1
Product Code
FPY
Sheet, Burn
1
Product Code
KGX
Tape And Bandage, Adhesive
1
Product Code
KMF
Bandage, Liquid
1
Product Code
LRS
I.V. Start Kit
2
Product Code
K
05
0654
AMSINO I.V. START KIT
2
Cleared 510(K)
K
00
1879
INFUSION IV SET
2
Cleared 510(K)
K
96
3722
IV START KIT
2
Cleared 510(K)
K
95
1167
EMS I.V. START KIT
2
Cleared 510(K)
K
95
0184
B. BRAUN IV START KITS
2
Cleared 510(K)
K
94
4041
PERSONAL HEARING SYSTEM
2
Cleared 510(K)
K
94
3941
SAFESTART VASCULAR ACCESS START KIT
2
Cleared 510(K)
K
93
5684
IV START KIT
2
Cleared 510(K)
K
94
2238
I.V. STARTPAK VASCULAR ACCESS START KIT
2
Cleared 510(K)
K
94
1469
IV START KIT
2
Cleared 510(K)
K
92
5018
IV PREP KIT W/O DRESSING (NON-STERILE)
2
Cleared 510(K)
K
92
5017
IV PREP KIT (NON-STERILE)
2
Cleared 510(K)
K
93
3041
COLD CD ASP MODULE, ITE
2
Cleared 510(K)
K
93
0196
CEPTI-SEAL I.V. PREP KIT
2
Cleared 510(K)
K
92
4538
IV START KIT
2
Cleared 510(K)
K
92
3361
I.V. START KIT, STERILE, DISPOSABLE
2
Cleared 510(K)
K
92
4811
I.V. START KIT
2
Cleared 510(K)
K
92
6031
PRO-PREP I.V. START/SCRUB-PREP/BLOOD CULTURE KIT
2
Cleared 510(K)
K
92
2533
IV START KIT CUSTOM SMP # A-Z
2
Cleared 510(K)
K
91
4475
IV START KIT
2
Cleared 510(K)
K
87
5315
I.V. START KITS
2
Cleared 510(K)
K
87
1731
TELSTAR PREWIRE SERIES
2
Cleared 510(K)
K
87
1281
IV START KIT
2
Cleared 510(K)
K
86
3796
CREATIVE CARE SYSTEMS' IV START KIT
2
Cleared 510(K)
K
86
3712
I.V. START KIT, STERILE, DISPOSABLES
2
Cleared 510(K)
K
85
2375
I.V. STARTER TRAY W/DYNADERM TRANSPARENT ADHESIVE
2
Cleared 510(K)
K
84
4614
IV START KIT
2
Cleared 510(K)
K
84
2898
CURITY I.V. START KIT
2
Cleared 510(K)
K
82
0490
IV START TRAY
2
Cleared 510(K)
K
76
0876
ARGYLE IV STARTER KIT (W/O DRUG)
2
Cleared 510(K)
MCY
Wound Dressing Kit
2
Product Code
MHW
Dressing, Compression
1
Product Code
NEC
Bandage, Liquid, Skin Protectant
1
Product Code
OXQ
Dressing Change Tray
1
Product Code
PYO
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
1
Product Code
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
SU
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
LRS
/
K875315
View Source
I.V. START KITS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K875315
510(k) Type
Traditional
Applicant
NI-MED, INC.
Country
United States
FDA Decision
Substantially Equivalent with Drug
Decision Date
2/17/1988
Days to Decision
50 days
FDA Browser
by
Innolitics
Anesthesiology
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
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
FPX
Strip, Adhesive, Closure, Skin
FPY
Sheet, Burn
KGX
Tape And Bandage, Adhesive
KMF
Bandage, Liquid
LRS
I.V. Start Kit
K
05
0654
AMSINO I.V. START KIT
K
00
1879
INFUSION IV SET
K
96
3722
IV START KIT
K
95
1167
EMS I.V. START KIT
K
95
0184
B. BRAUN IV START KITS
K
94
4041
PERSONAL HEARING SYSTEM
K
94
3941
SAFESTART VASCULAR ACCESS START KIT
K
93
5684
IV START KIT
K
94
2238
I.V. STARTPAK VASCULAR ACCESS START KIT
K
94
1469
IV START KIT
K
92
5018
IV PREP KIT W/O DRESSING (NON-STERILE)
K
92
5017
IV PREP KIT (NON-STERILE)
K
93
3041
COLD CD ASP MODULE, ITE
K
93
0196
CEPTI-SEAL I.V. PREP KIT
K
92
4538
IV START KIT
K
92
3361
I.V. START KIT, STERILE, DISPOSABLE
K
92
4811
I.V. START KIT
K
92
6031
PRO-PREP I.V. START/SCRUB-PREP/BLOOD CULTURE KIT
K
92
2533
IV START KIT CUSTOM SMP # A-Z
K
91
4475
IV START KIT
K
87
5315
I.V. START KITS
K
87
1731
TELSTAR PREWIRE SERIES
K
87
1281
IV START KIT
K
86
3796
CREATIVE CARE SYSTEMS' IV START KIT
K
86
3712
I.V. START KIT, STERILE, DISPOSABLES
K
85
2375
I.V. STARTER TRAY W/DYNADERM TRANSPARENT ADHESIVE
K
84
4614
IV START KIT
K
84
2898
CURITY I.V. START KIT
K
82
0490
IV START TRAY
K
76
0876
ARGYLE IV STARTER KIT (W/O DRUG)
MCY
Wound Dressing Kit
MHW
Dressing, Compression
NEC
Bandage, Liquid, Skin Protectant
OXQ
Dressing Change Tray
PYO
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
LRS
/
K875315
View Source
I.V. START KITS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K875315
510(k) Type
Traditional
Applicant
NI-MED, INC.
Country
United States
FDA Decision
Substantially Equivalent with Drug
Decision Date
2/17/1988
Days to Decision
50 days