Footprint Medical Silicone Umbilical Catheter
FDA 510(k) K091214 · Footprint Medical
510(k) numberK091214
Submission
- Device name
- Footprint Medical Silicone Umbilical Catheter
- Applicant
- Footprint Medical
San Antonio, TX, US - Received
- April 27, 2009
- Decision date
- September 25, 2009
- 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 |
| 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 |
| K951738 | Argyle Neo-Sert Triple Lumen Umbilical Vessel CatheterFOS · Traditional | Sherwood Medical Co. | 09/29/1995SE |
More from Sherwood Medical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K130507 | Footprint Medical Polyurethane Picc CatheterLJS · Special | 06/03/2013SE |
| K120304 | Footprint Medical Polyurethane Umbilical CatheterFOS · Special | 03/01/2012SE |
| K102548 | Footprint Medical Polyurethane Feeding TubeKNT · Traditional | 11/26/2010SE |
| K093026 | Footprint Medical 1.9 FR Picc IntroducerDYB · Traditional | 02/24/2010SE |
| K093252 | Footprint Medical Peripherally Inserted Central CatheterLJS · Special | 12/17/2009SE |
| K091213 | Footprint Medical Umbilical Catheter, Dual LumenFOS · Traditional | 09/25/2009SE |
| K091488 | Footprint Medical Peripherally Inserted Central Catheter, Model S1PIC1.9-CLJS · Traditional | 09/14/2009SE |
| K090576 | Footprint Urinary Drainage CatheterEZD · Traditional | 08/12/2009SE |
| K090559 | Footprint Medical Silicone Feeding TubeKNT · Traditional | 05/04/2009SE |
Questions and answers
When was Footprint Medical Silicone Umbilical Catheter cleared by the FDA?
Footprint Medical Silicone Umbilical Catheter (K091214) received a 510(k) decision of Substantially Equivalent on September 25, 2009, 151 days after the submission was received.
What is the product code of K091214?
The FDA product code is FOS – Catheter, Umbilical Artery, a Class II (moderate risk) device regulated under 21 CFR 880.5200.