Umbili-Cath
FDA 510(k) K940870 · Gesco Intl., Inc.
510(k) numberK940870
Submission
- Device name
- Umbili-Cath
- Applicant
- Gesco Intl., Inc.
San Antonio, TX, US - Received
- February 25, 1994
- Decision date
- August 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FOS – Catheter, Umbilical Artery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
Other 510(k)s with product code FOS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201697 | Umbilical Vessels CatheterFOS · Traditional | Haolang Medical USA Corporation | 05/06/2021SE |
| K130725 | Modified Argyle Polyurethane Umbilical Vessel Catheter 2.5FR, 3.5FR, 5 Fr.FOS · Special | Covidien Lp, Formerly Registered AS Kendall | 04/17/2013SE |
| K120304 | Footprint Medical Polyurethane Umbilical CatheterFOS · Special | Footprint Medical, Inc. | 03/01/2012SE |
| K091214 | Footprint Medical Silicone Umbilical CatheterFOS · Traditional | Footprint Medical | 09/25/2009SE |
| K091213 | Footprint Medical Umbilical Catheter, Dual LumenFOS · Traditional | Footprint Medical | 09/25/2009SE |
| K081515 | Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0FOS · Special | Neomed, Inc. | 07/21/2008SE |
| K073596 | Neomed Single Lumen Umbilical CatheterFOS · Traditional | Neomed, Inc. | 02/22/2008SE |
| K981630 | Vygon Double Lumen Umbilical CatheterFOS · Traditional | Schiff & Co. | 10/01/1998SE |
| K963972 | Neo-Care Dual Lumen Umbilical CatheterFOS · Traditional | Klein-Baker Medical, Inc. | 12/24/1996SE |
| K954300 | Argyle Neo-Sert Hydrophilic Polyurethane Umbilical Vessel Catheter Insertion TrayFOS · Traditional | Sherwood Medical Co. | 12/13/1995SE |
More from Sherwood Medical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K954422 | Per-Q-Cath Mid-LineLJS · Traditional | 12/15/1995SE |
| K940953 | Umbili-Cath-SFOS · Traditional | 08/02/1994SE |
| K940952 | Umbili-Cath-S-DlFOS · Traditional | 07/29/1994SE |
| K941672 | Uri-Cath CatheterGBM · Traditional | 05/16/1994SE |
| K941232 | Thora-CathJOL · Traditional | 05/11/1994SE |
| K940871 | Umbili-Cath-PFOS · Traditional | 04/29/1994SE |
| K931989 | Ventri-CathJXG · Traditional | 07/21/1993SE |
| K926063 | Per-Q-Cath Dressing Change TrayMCY · Traditional | 06/07/1993SEKD |
| K923591 | Pala-NateBTR · Traditional | 03/16/1993SE |
| K915167 | Gesco Per-Q-Cath Catheter IntroducerDYB · Traditional | 01/27/1992SE |
Questions and answers
When was Umbili-Cath cleared by the FDA?
Umbili-Cath (K940870) received a 510(k) decision of Substantially Equivalent on August 2, 1994, 158 days after the submission was received.
What is the product code of K940870?
The FDA product code is FOS – Catheter, Umbilical Artery, a Class II (moderate risk) device regulated under 21 CFR 880.5200.