Product Code: FOS
FDA class 2
21 CFR 880.5200
Catheter, Umbilical Artery
General Hospital
The Umbilical Artery Catheter is a thin flexible tube inserted into an umbilical artery of a critically ill newborn to enable continuous blood pressure monitoring, blood sampling, and fluid or medication administration without repeated vascular punctures. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FOS, regulated under 21 CFR 880.5200 in the General Hospital specialty. This device is eligible for third-party review.
510(k)s
34
FEI Numbers
16
Registration Numbers
17
Unique Applicants
19
Years Active
44
Basic Information
- Product Code
- FOS
- Device Class
- FDA class 2
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 34 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K201697 | Umbilical Vessels Catheter | May 06, 2021 | Substantially Equivalent | Haolang Medical USA Corporation |
| K130725 | MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. | Apr 17, 2013 | Substantially Equivalent | COVIDIEN LP, FORMERLY REGISTERED AS KENDALL |
| K120304 | FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER | Mar 01, 2012 | Substantially Equivalent | FOOTPRINT MEDICAL INC. |
| K091214 | FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER | Sep 25, 2009 | Substantially Equivalent | FOOTPRINT MEDICAL |
| K091213 | FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN | Sep 25, 2009 | Substantially Equivalent | FOOTPRINT MEDICAL |
| K081515 | NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 | Jul 21, 2008 | Substantially Equivalent | NEOMED, INC. |
| K073596 | NEOMED SINGLE LUMEN UMBILICAL CATHETER | Feb 22, 2008 | Substantially Equivalent | NEOMED, INC. |
| K981630 | VYGON DOUBLE LUMEN UMBILICAL CATHETER | Oct 01, 1998 | Substantially Equivalent | SCHIFF & CO. |
| K963972 | NEO-CARE DUAL LUMEN UMBILICAL CATHETER | Dec 24, 1996 | Substantially Equivalent | KLEIN-BAKER MEDICAL, INC. |
| K954300 | ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY | Dec 13, 1995 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K951738 | ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER | Sep 29, 1995 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K951737 | ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAY | Sep 28, 1995 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K942353 | CENTURION UMBILICAL CATHETER | Aug 15, 1995 | Substantially Equivalent | TRI-STATE HOSPITAL SUPPLY CORP. |
| K941429 | IV CATHETER AND OBTURATOR | Jan 04, 1995 | Substantially Equivalent | BECTON DICKINSON VASCULAR ACCESS, INC. |
| K942827 | SENTRY INSERTION TRAY | Nov 02, 1994 | Substantially Equivalent | SENTRY MEDICAL PRODUCTS, INC. |
| K941814 | ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER | Sep 30, 1994 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K942564 | ARGYLE NEO-SERT | Aug 25, 1994 | Unknown | SHERWOOD MEDICAL CO. |
| K940953 | UMBILI-CATH-S | Aug 02, 1994 | Substantially Equivalent | GESCO INTL., INC. |
| K940870 | UMBILI-CATH | Aug 02, 1994 | Substantially Equivalent | GESCO INTL., INC. |
| K940952 | UMBILI-CATH-S-DL | Jul 29, 1994 | Substantially Equivalent | GESCO INTL., INC. |
| K940871 | UMBILI-CATH-P | Apr 29, 1994 | Substantially Equivalent | GESCO INTL., INC. |
| K921374 | VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER | Oct 26, 1992 | Substantially Equivalent | VYGON CORP. |
| K921352 | VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH | Oct 26, 1992 | Substantially Equivalent | VYGON CORP. |
| K911607 | GESCO UMBILI-CATH | Jun 11, 1991 | Substantially Equivalent | GESCO INTL., INC. |
| K896041 | GESCO DUAL LUMEN UMBILICATH II-DL | Apr 17, 1990 | Unknown | GESCO INTL., INC. |
| K890685 | BARD UMBILICAL VESSEL CATHETER | Feb 28, 1989 | Substantially Equivalent | C.R. BARD, INC. |
| K850884 | ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER | Oct 17, 1985 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K851005 | XRO UMBILICAL CATHETER-CODE 270 | May 21, 1985 | Substantially Equivalent | VYGON CORP. |
| K840339 | UMBILICAL VESSEL CATHETER | Jul 25, 1984 | Substantially Equivalent | CATHETER TECHNOLOGY CORP. |
| K831988 | INTRAVASCULAR CATHETER | Nov 08, 1983 | Substantially Equivalent | C.R. BARD, INC. |
| K802414 | UMBILI-CATH CATHETER | Oct 23, 1980 | Substantially Equivalent | INT'L CORP. |
| K771022 | CATHETER, UMBILICAR ARTERY | Nov 29, 1977 | Substantially Equivalent | AXIOM MEDICAL, INC. |
| K771891 | CATHETER, UMBILICAL, VICRA | Nov 02, 1977 | Substantially Equivalent | TRAVENOL LABORATORIES, S.A. |
| K760966 | CATHETER, UMBILICAL ARTERY | Jan 26, 1977 | Substantially Equivalent | SHERWOOD MEDICAL INDUSTRIES |
FEI Numbers
This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.