FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UMBILI-CATH
K Number: K940870
·
Decision Aug 2, 1994
Classifications
1
FEI Numbers
16
Registration Numbers
17
Same Product Code
33
Applicant Total
26
Review Days
158
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Basic Information
- Device Name
- UMBILI-CATH
- K Number
- K940870
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gesco Intl., Inc.
- Date Received
- February 25, 1994
- Decision Date
- August 2, 1994
- 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
·General Hospital
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
Other Clearances by Gesco Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954422 | PER-Q-CATH MID-LINE | Dec 15, 1995 | Substantially Equivalent |
| K940953 | UMBILI-CATH-S | Aug 2, 1994 | Substantially Equivalent |
| K940952 | UMBILI-CATH-S-DL | Jul 29, 1994 | Substantially Equivalent |
| K941672 | URI-CATH CATHETER | May 16, 1994 | Substantially Equivalent |
| K941232 | THORA-CATH | May 11, 1994 | Substantially Equivalent |
| K940871 | UMBILI-CATH-P | Apr 29, 1994 | Substantially Equivalent |
| K931989 | VENTRI-CATH | Jul 21, 1993 | Substantially Equivalent |
| K926063 | PER-Q-CATH DRESSING CHANGE TRAY | Jun 7, 1993 | Unknown |
| K923591 | PALA-NATE | Mar 16, 1993 | Substantially Equivalent |
| K915167 | GESCO PER-Q-CATH CATHETER INTRODUCER | Jan 27, 1992 | Substantially Equivalent |