FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATHETER, UMBILICAR ARTERY
K Number: K771022
·
Decision Nov 29, 1977
Classifications
1
FEI Numbers
16
Registration Numbers
17
Same Product Code
33
Applicant Total
28
Review Days
176
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Basic Information
- Device Name
- CATHETER, UMBILICAR ARTERY
- K Number
- K771022
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Axiom Medical, Inc.
- Date Received
- June 6, 1977
- Decision Date
- November 29, 1977
- 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.
Umbilical Vessels Catheter
FDA 510(k)
FDA Class 2
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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
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FDA Class 2
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FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN
FDA 510(k)
FDA Class 2
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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
Other Clearances by Axiom Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993592 | AXIOM MULTIPURPOSE WOUND DRAIN | May 17, 2000 | Substantially Equivalent |
| K971851 | INTERPLEURAL ANESTHESIA CATHETER | Jan 22, 1998 | Substantially Equivalent |
| K965146 | FLAT CLOSED WOUND DRAIN WITH TROCAR | Mar 10, 1997 | Substantially Equivalent |
| K934895 | GLASSMAN SILICONE CATHETER | Oct 13, 1994 | Substantially Equivalent |
| K922760 | ATRAUM WOUND DRESSING--MODIFICATION | Oct 30, 1992 | Substantially Equivalent |
| K905422 | PVC ROUND WOUND DRAINS | Feb 11, 1991 | Substantially Equivalent |
| K904218 | SUCTION SYSTEM | Oct 31, 1990 | Substantially Equivalent |
| K904133 | DISPOSABLE FLUID COLLECTION BAG | Oct 11, 1990 | Substantially Equivalent |
| K863247 | AXIOM TROCAR THORACIC CATHETER | Aug 29, 1986 | Substantially Equivalent |
| K861306 | SUCTION SYSTEM | Jun 9, 1986 | Substantially Equivalent |