Centurion Umbilical Catheter
FDA 510(k) K942353 · Tri-State Hospital Supply Corp.
510(k) numberK942353
Submission
- Device name
- Centurion Umbilical Catheter
- Applicant
- Tri-State Hospital Supply Corp.
Howell, MI, US - Received
- May 17, 1994
- Decision date
- August 15, 1995
- 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 |
|---|---|---|
| K080448 | Centurion Protective Restraint, SCR SeriesFMQ · Traditional | 08/28/2008SE |
| K080524 | Centurion Sorbaview OTCNAD · Traditional | 04/23/2008SE |
| K945977 | Centurion(R) Site Guard(R) Transparent Dressing/Transpaent Film DressingMGP · Traditional | 03/29/1995SE |
| K931748 | Centlurion Disp Steri Dental/Hygiene Pack/TraysLJT · Traditional | 02/25/1994SESK |
| K935491 | Centurion Mogen Clamp/Circumcision (Ster/Non Ster)HFX · Traditional | 02/17/1994SE |
| K923812 | Centurion Disposable InstrumentsMDM · Traditional | 12/17/1992SE |
| K910906 | Centurion Kleen-Needle System I.V. Extension SetsFPK · Traditional | 04/01/1991SE |
| K897100 | Centurion Vaginal SpeculumHIC · Traditional | 03/16/1990SE |
| K896320 | Centurion Kleen-Needle SystemFMI · Traditional | 01/11/1990SE |
| K893647 | Copolyester Film DressingKGN · Traditional | 10/16/1989SE |
Questions and answers
When was Centurion Umbilical Catheter cleared by the FDA?
Centurion Umbilical Catheter (K942353) received a 510(k) decision of Substantially Equivalent on August 15, 1995, 455 days after the submission was received.
What is the product code of K942353?
The FDA product code is FOS – Catheter, Umbilical Artery, a Class II (moderate risk) device regulated under 21 CFR 880.5200.