Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0
FDA 510(k) K081515 · Neomed, Inc.
510(k) numberK081515
Submission
- Device name
- Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0
- Applicant
- Neomed, Inc.
Swanee, GA, US - Received
- May 30, 2008
- Decision date
- July 21, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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 |
| 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.
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| K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect…PNR · Traditional | 06/17/2016SE |
| K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsPNR · Traditional | 12/17/2015SE |
| K143344 | NeoMed NeoConnect Enteral Syringes with ENFit ConnectorPNR · Traditional | 04/09/2015SE |
| K122373 | Neomed Oral/Enteral SyringeFMF · Special | 09/20/2012SE |
| K120182 | Neomed Gastrointestinal Tube and AccessoriesKNT · Traditional | 04/19/2012SE |
| K100288 | Neomed Enteral Only Extension SetKNT · Traditional | 08/03/2010SE |
| K092908 | Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO…FMF · Traditional | 03/10/2010SE |
| K082238 | Neomed Polyurethane Feeding TubeFPD · Special | 10/01/2008SE |
| K073596 | Neomed Single Lumen Umbilical CatheterFOS · Traditional | 02/22/2008SE |
Questions and answers
When was Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0 cleared by the FDA?
Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0 (K081515) received a 510(k) decision of Substantially Equivalent on July 21, 2008, 52 days after the submission was received.
What is the product code of K081515?
The FDA product code is FOS – Catheter, Umbilical Artery, a Class II (moderate risk) device regulated under 21 CFR 880.5200.