Product code FOS
- Device name
- Catheter, Umbilical Artery
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5200
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201697 | Umbilical Vessels Catheter | Haolang Medical USA Corporation | 2021-05-06 |
| K130725 | MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. | Covidien Lp, Formerly Registered AS Kendall | 2013-04-17 |
| K120304 | FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER | Footprint Medical, Inc. | 2012-03-01 |
| K091213 | FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN | Footprint Medical | 2009-09-25 |
| K091214 | FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER | Footprint Medical | 2009-09-25 |
| K081515 | NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 | Neomed, Inc. | 2008-07-21 |
| K073596 | NEOMED SINGLE LUMEN UMBILICAL CATHETER | Neomed, Inc. | 2008-02-22 |
| K981630 | VYGON DOUBLE LUMEN UMBILICAL CATHETER | Schiff & Co. | 1998-10-01 |
| K963972 | NEO-CARE DUAL LUMEN UMBILICAL CATHETER | Klein-Baker Medical, Inc. | 1996-12-24 |
| K954300 | ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY | Sherwood Medical Co. | 1995-12-13 |
| K951738 | ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER | Sherwood Medical Co. | 1995-09-29 |
| K951737 | ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAY | Sherwood Medical Co. | 1995-09-28 |
| K942353 | CENTURION UMBILICAL CATHETER | Tri-State Hospital Supply Corp. | 1995-08-15 |
| K941429 | IV CATHETER AND OBTURATOR | Becton Dickinson Vascular Access, Inc. | 1995-01-04 |
| K942827 | SENTRY INSERTION TRAY | Sentry Medical Products, Inc. | 1994-11-02 |
| K941814 | ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER | Sherwood Medical Co. | 1994-09-30 |
| K942564 | ARGYLE NEO-SERT | Sherwood Medical Co. | 1994-08-25 |
| K940870 | UMBILI-CATH | Gesco Intl., Inc. | 1994-08-02 |
| K940953 | UMBILI-CATH-S | Gesco Intl., Inc. | 1994-08-02 |
| K940952 | UMBILI-CATH-S-DL | Gesco Intl., Inc. | 1994-07-29 |
| K940871 | UMBILI-CATH-P | Gesco Intl., Inc. | 1994-04-29 |
| K921374 | VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER | Vygon Corp. | 1992-10-26 |
| K921352 | VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH | Vygon Corp. | 1992-10-26 |
| K911607 | GESCO UMBILI-CATH | Gesco Intl., Inc. | 1991-06-11 |
| K896041 | GESCO DUAL LUMEN UMBILICATH II-DL | Gesco Intl., Inc. | 1990-04-17 |
| K890685 | BARD UMBILICAL VESSEL CATHETER | C.R. Bard, Inc. | 1989-02-28 |
| K850884 | ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER | Sherwood Medical Co. | 1985-10-17 |
| K851005 | XRO UMBILICAL CATHETER-CODE 270 | Vygon Corp. | 1985-05-21 |
| K840339 | UMBILICAL VESSEL CATHETER | Catheter Technology Corp. | 1984-07-25 |
| K831988 | INTRAVASCULAR CATHETER | C.R. Bard, Inc. | 1983-11-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10192253040289 | Argyle | Cardinal Health 200, LLC | 2025-01-08 |
| 10192253040401 | Argyle | Cardinal Health 200, LLC | 2025-01-08 |
| 10192253040395 | Argyle | Cardinal Health 200, LLC | 2025-01-08 |
| 10192253040210 | Argyle | Cardinal Health 200, LLC | 2025-01-08 |
| 10192253040203 | Argyle | Cardinal Health 200, LLC | 2025-01-08 |
| 10192253040326 | Argyle | Cardinal Health 200, LLC | 2025-01-08 |
| 10192253040333 | Argyle | Cardinal Health 200, LLC | 2025-01-08 |
| 10192253040340 | Argyle | Cardinal Health 200, LLC | 2025-01-08 |
| 10192253040296 | Argyle | Cardinal Health 200, LLC | 2024-10-16 |
| 10192253040357 | Argyle | Cardinal Health 200, LLC | 2024-10-16 |
| 10192253040388 | Argyle | Cardinal Health 200, LLC | 2024-09-30 |
| 10192253040371 | Argyle | Cardinal Health 200, LLC | 2024-08-23 |
| 10192253040364 | Argyle | Cardinal Health 200, LLC | 2024-07-12 |
| 10192253040302 | Argyle | Cardinal Health 200, LLC | 2024-06-20 |
| 10192253040319 | Argyle | Cardinal Health 200, LLC | 2024-06-06 |
| 10884521070363 | Argyle | Cardinal Health, Inc. | 2016-09-24 |
| 10884521070370 | Argyle | Cardinal Health, Inc. | 2016-09-24 |
| H67143850050 | UMBILI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67142850050 | UMBILI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67142835050 | UMBILI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67142828050 | UMBILI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67142750050 | UMBILI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67142735050 | UMBILI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67141865050 | UMBILI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67141850050 | UMBILI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67141835050 | UMBILI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67141828050 | UMBILI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67141780050 | UMBILI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67141750050 | UMBILI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H67141735050 | UMBILI-CATH | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |