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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)
Show All 30 Submissions
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
/
K001879
View Source
INFUSION IV SET
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001879
510(k) Type
Traditional
Applicant
NIRVI INTL. USA
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/20/2001
Days to Decision
518 days
Submission Type
Statement
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
Show All 30 Submissions
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
/
K001879
View Source
INFUSION IV SET
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001879
510(k) Type
Traditional
Applicant
NIRVI INTL. USA
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/20/2001
Days to Decision
518 days
Submission Type
Statement