FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Umbilical Vessels Catheter
K Number: K201697
·
Decision May 6, 2021
Classifications
1
FEI Numbers
16
Registration Numbers
17
Same Product Code
33
Applicant Total
3
Review Days
318
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
- Umbilical Vessels Catheter
- K Number
- K201697
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Haolang Medical USA Corporation
- Date Received
- June 22, 2020
- Decision Date
- May 6, 2021
- Product Code
- FOS
- 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 |
|---|---|---|---|
| FOS | Catheter, Umbilical Artery | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FOS), ordered by most recent decision date.
MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.
FDA 510(k)
FDA Class 2
·General Hospital
FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN
FDA 510(k)
FDA Class 2
·General Hospital
FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0
FDA 510(k)
FDA Class 2
·General Hospital
NEOMED SINGLE LUMEN UMBILICAL CATHETER
FDA 510(k)
FDA Class 2
·General Hospital