Vygon Double Lumen Umbilical Catheter
FDA 510(k) K981630 · Schiff & Co.
510(k) numberK981630
Submission
- Device name
- Vygon Double Lumen Umbilical Catheter
- Applicant
- Schiff & Co.
West Cadwell, NJ, US - Received
- May 7, 1998
- Decision date
- October 1, 1998
- 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 |
| 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 |
| K951738 | Argyle Neo-Sert Triple Lumen Umbilical Vessel CatheterFOS · Traditional | Sherwood Medical Co. | 09/29/1995SE |
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| K974141 | Plus Reusable ResuscitatorBTM · Traditional | 05/21/1998SE |
| K954448 | Viotec V-2200 Ultraviolet Germicidal Air Purification SystemFRA · Traditional | 10/28/1996SE |
| K955085 | Hm-Cap Eia Test (Modification)LYR · Traditional | 02/09/1996SE |
| K944159 | Hm-Cap Eia KitLYR · Traditional | 07/18/1995SE |
| K943521 | Viotec 1400 Series Ultraviolet Germicidal FixtureFRA · Traditional | 02/14/1995SE |
| K896684 | Kemble Liquid Handling System DispenserJQW · Traditional | 04/16/1990SE |
| K894617 | Olympus Pk-Tp System Reactive ControlGMI · Traditional | 10/31/1989SE |
Questions and answers
When was Vygon Double Lumen Umbilical Catheter cleared by the FDA?
Vygon Double Lumen Umbilical Catheter (K981630) received a 510(k) decision of Substantially Equivalent on October 1, 1998, 147 days after the submission was received.
What is the product code of K981630?
The FDA product code is FOS – Catheter, Umbilical Artery, a Class II (moderate risk) device regulated under 21 CFR 880.5200.