FOS — Catheter, Umbilical Artery Class II
FDA product code FOS covers "Catheter, Umbilical Artery", a Class II medical device regulated under 21 CFR 880.5200. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FOS
- Device Class
- Class II
- Regulation Number
- 880.5200
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201697 | haolang medical usa corporation | Umbilical Vessels Catheter | May 6, 2021 |
| K130725 | covidien lp, formerly registered as kendall | MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. | April 17, 2013 |
| K120304 | footprint medical | FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER | March 1, 2012 |
| K091214 | footprint medical | FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER | September 25, 2009 |
| K091213 | footprint medical | FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN | September 25, 2009 |
| K081515 | neomed | NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 | July 21, 2008 |
| K073596 | neomed | NEOMED SINGLE LUMEN UMBILICAL CATHETER | February 22, 2008 |
| K981630 | schiff and | VYGON DOUBLE LUMEN UMBILICAL CATHETER | October 1, 1998 |
| K963972 | klein-baker medical | NEO-CARE DUAL LUMEN UMBILICAL CATHETER | December 24, 1996 |
| K954300 | sherwood medical | ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRA | December 13, 1995 |
| K951738 | sherwood medical | ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER | September 29, 1995 |
| K951737 | sherwood medical | ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAY | September 28, 1995 |
| K942353 | tri-state hospital supply | CENTURION UMBILICAL CATHETER | August 15, 1995 |
| K941429 | becton dickinson vascular access | IV CATHETER AND OBTURATOR | January 4, 1995 |
| K942827 | sentry medical products | SENTRY INSERTION TRAY | November 2, 1994 |
| K941814 | sherwood medical | ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER | September 30, 1994 |
| K942564 | sherwood medical | ARGYLE NEO-SERT | August 25, 1994 |
| K940953 | gesco intl | UMBILI-CATH-S | August 2, 1994 |
| K940870 | gesco intl | UMBILI-CATH | August 2, 1994 |
| K940952 | gesco intl | UMBILI-CATH-S-DL | July 29, 1994 |