FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IVID
K Number: K950200
·
Decision Mar 24, 1995
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
63
Applicant Total
1
Review Days
65
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- IVID
- K Number
- K950200
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Scott/Ross Designs, Inc.
- Date Received
- January 18, 1995
- Decision Date
- March 24, 1995
- Product Code
- FPK
- 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 |
|---|---|---|---|
| FPK | Tubing, Fluid Delivery | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPK), ordered by most recent decision date.
MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
FDA 510(k)
FDA Class 2
·General Hospital
DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES
FDA 510(k)
FDA Class 2
·General Hospital
LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526
FDA 510(k)
FDA Class 2
·General Hospital
MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1
FDA 510(k)
FDA Class 2
·General Hospital
EMPOWER TRANSFER SET, (CAT. NO. 7725)
FDA 510(k)
FDA Class 2
·General Hospital
MEDRAD SWABBABLE VALVE TRANSFER SET
FDA 510(k)
FDA Class 2
·General Hospital