IV Catheter and Obturator
FDA 510(k) K941429 · Becton Dickinson Vascular Access, Inc.
510(k) numberK941429
Submission
- Device name
- IV Catheter and Obturator
- Applicant
- Becton Dickinson Vascular Access, Inc.
Nogales, Sonora, MX - Received
- March 24, 1994
- Decision date
- January 4, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
|---|---|---|
| K971339 | Insyte, Insyte-W, Insyte Autoguard CathetersFOZ · Traditional | 12/24/1997SE |
| K970259 | E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetFPA · Traditional | 04/08/1997SE |
| K964050 | First Midcath CatheterFOZ · Traditional | 01/06/1997SE |
| K964049 | First Midcath Catheter with Dual LumensFOZ · Traditional | 01/06/1997SE |
| K964048 | First Midcath Catheter KitFOZ · Traditional | 01/06/1997SE |
| K954906 | First Picc Introducer CatheterDYB · Traditional | 04/08/1996SE |
| K952861 | Angiocath & Insyte Autoguard CathetersFOZ · Traditional | 07/31/1995SE |
| K952757 | Angiocath, Novbalon, Angio-Set Intravascular & Angiocath Introduction Drainage CatheterFOZ · Traditional | 07/31/1995SE |
| K952053 | E-Z Set, Saf-T E-Z Set, and Minicath Infusion SetsFPA · Traditional | 05/31/1995SE |
| K950301 | Angiocath(R) Nonvalon(R) and Angio-Set(R) IV CathetersFOZ · Traditional | 04/18/1995SE |
Questions and answers
When was IV Catheter and Obturator cleared by the FDA?
IV Catheter and Obturator (K941429) received a 510(k) decision of Substantially Equivalent on January 4, 1995, 286 days after the submission was received.
What is the product code of K941429?
The FDA product code is FOS – Catheter, Umbilical Artery, a Class II (moderate risk) device regulated under 21 CFR 880.5200.