FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VYGON DOUBLE LUMEN UMBILICAL CATHETER
K Number: K981630
·
Decision Oct 1, 1998
Classifications
1
FEI Numbers
16
Registration Numbers
17
Same Product Code
33
Applicant Total
15
Review Days
147
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Basic Information
- Device Name
- VYGON DOUBLE LUMEN UMBILICAL CATHETER
- K Number
- K981630
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Schiff & Co.
- Date Received
- May 7, 1998
- Decision Date
- October 1, 1998
- 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.
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NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0
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| K896684 | KEMBLE LIQUID HANDLING SYSTEM DISPENSER | Apr 16, 1990 | Substantially Equivalent |
| K894617 | OLYMPUS PK-TP SYSTEM REACTIVE CONTROL | Oct 31, 1989 | Substantially Equivalent |