FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VASCULAR ACCESS PORT CONTINUOUS INFUSION SETS
K Number: K904886
·
Decision Jan 11, 1991
Classifications
1
FEI Numbers
437
Registration Numbers
437
Same Product Code
1167
Applicant Total
1
Review Days
77
Basic Information
- Device Name
- VASCULAR ACCESS PORT CONTINUOUS INFUSION SETS
- K Number
- K904886
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- FLORIDA INFUSION SERVICES, INC.
- Date Received
- October 26, 1990
- Decision Date
- January 11, 1991
- Product Code
- FPA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPA), ordered by most recent decision date.
Clave Neutral-Displacement Needlefree Connectors
FDA 510(k)
FDA Class 2
·General Hospital
SteadiSet Infusion Set
FDA 510(k)
FDA Class 2
·General Hospital
JetCan® Pro Safety Huber Needle
FDA 510(k)
FDA Class 2
·General Hospital
Solution Administration Sets
FDA 510(k)
FDA Class 2
·General Hospital
Intravascular Extension Sets and Accessories
FDA 510(k)
FDA Class 2
·General Hospital
Lyka® PORT Needle Free Access Device (4170Y)
FDA 510(k)
FDA Class 2
·General Hospital