FOS · Catheter, Umbilical Artery
General Hospital · 21 CFR 880.5200 · Class 2
Overview
| Product Code | FOS |
|---|---|
| Device Name | Catheter, Umbilical Artery |
| Regulation | 21 CFR 880.5200 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 34)
Showing 20 most recent of 34 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201697 | Umbilical Vessels Catheter | Haolang Medical USA Corporation | May 6, 2021 | SESE |
| K130725 | MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. | Covidien Lp, Formerly Registered AS Kendall | Apr 17, 2013 | SESE |
| K120304 | FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER | Footprint Medical, Inc. | Mar 1, 2012 | SESE |
| K091214 | FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER | Footprint Medical | Sep 25, 2009 | SESE |
| K091213 | FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN | Footprint Medical | Sep 25, 2009 | SESE |
| K081515 | NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 | Neomed, Inc. | Jul 21, 2008 | SESE |
| K073596 | NEOMED SINGLE LUMEN UMBILICAL CATHETER | Neomed, Inc. | Feb 22, 2008 | SESE |
| K981630 | VYGON DOUBLE LUMEN UMBILICAL CATHETER | Schiff & Co. | Oct 1, 1998 | SESE |
| K963972 | NEO-CARE DUAL LUMEN UMBILICAL CATHETER | Klein-Baker Medical, Inc. | Dec 24, 1996 | SESE |
| K954300 | ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY | Sherwood Medical Co. | Dec 13, 1995 | SESE |
| K951738 | ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER | Sherwood Medical Co. | Sep 29, 1995 | SESE |
| K951737 | ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAY | Sherwood Medical Co. | Sep 28, 1995 | SESE |
| K942353 | CENTURION UMBILICAL CATHETER | Tri-State Hospital Supply Corp. | Aug 15, 1995 | SESE |
| K941429 | IV CATHETER AND OBTURATOR | Becton Dickinson Vascular Access, Inc. | Jan 4, 1995 | SESE |
| K942827 | SENTRY INSERTION TRAY | Sentry Medical Products, Inc. | Nov 2, 1994 | SESE |
| K941814 | ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER | Sherwood Medical Co. | Sep 30, 1994 | SESE |
| K942564 | ARGYLE NEO-SERT | Sherwood Medical Co. | Aug 25, 1994 | SEKD |
| K940953 | UMBILI-CATH-S | Gesco Intl., Inc. | Aug 2, 1994 | SESE |
| K940870 | UMBILI-CATH | Gesco Intl., Inc. | Aug 2, 1994 | SESE |
| K940952 | UMBILI-CATH-S-DL | Gesco Intl., Inc. | Jul 29, 1994 | SESE |
Top Applicants
- Gesco Intl., Inc. — 6 clearances
- Sherwood Medical Co. — 6 clearances
- Vygon Corp. — 3 clearances
- C.R. Bard, Inc. — 2 clearances
- Footprint Medical — 2 clearances
