FDA Product Code
FDA Product Code FOS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5200
510(k) Clearances — 34 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K201697 | Umbilical Vessels Catheter | Haolang Medical USA Corporation | 2021-05-06 | Traditional | PDF ↗ |
| K130725 | MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. | Covidien Lp, Formerly Registered AS Kendall | 2013-04-17 | Special | PDF ↗ |
| K120304 | FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER | Footprint Medical, Inc. | 2012-03-01 | Special | PDF ↗ |
| K091214 | FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER | Footprint Medical | 2009-09-25 | Traditional | PDF ↗ |
| K091213 | FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN | Footprint Medical | 2009-09-25 | Traditional | PDF ↗ |
| K081515 | NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 | Neomed, Inc. | 2008-07-21 | Special | PDF ↗ |
| K073596 | NEOMED SINGLE LUMEN UMBILICAL CATHETER | Neomed, Inc. | 2008-02-22 | Traditional | PDF ↗ |
| K981630 | VYGON DOUBLE LUMEN UMBILICAL CATHETER | Schiff & Co. | 1998-10-01 | Traditional | PDF ↗ |
| K963972 | NEO-CARE DUAL LUMEN UMBILICAL CATHETER | Klein-Baker Medical, Inc. | 1996-12-24 | Traditional | PDF ↗ |
| K954300 | ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY | Sherwood Medical Co. | 1995-12-13 | Traditional | PDF ↗ |
| K951738 | ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER | Sherwood Medical Co. | 1995-09-29 | Traditional | PDF ↗ |
| K951737 | ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAY | Sherwood Medical Co. | 1995-09-28 | Traditional | PDF ↗ |
| K942353 | CENTURION UMBILICAL CATHETER | Tri-State Hospital Supply Corp. | 1995-08-15 | Traditional | PDF ↗ |
| K941429 | IV CATHETER AND OBTURATOR | Becton Dickinson Vascular Access, Inc. | 1995-01-04 | Traditional | PDF ↗ |
| K942827 | SENTRY INSERTION TRAY | Sentry Medical Products, Inc. | 1994-11-02 | Traditional | PDF ↗ |
| K941814 | ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER | Sherwood Medical Co. | 1994-09-30 | Traditional | PDF ↗ |
| K942564 | ARGYLE NEO-SERT | Sherwood Medical Co. | 1994-08-25 | Traditional | PDF ↗ |
| K940953 | UMBILI-CATH-S | Gesco Intl., Inc. | 1994-08-02 | Traditional | PDF ↗ |
| K940870 | UMBILI-CATH | Gesco Intl., Inc. | 1994-08-02 | Traditional | PDF ↗ |
| K940952 | UMBILI-CATH-S-DL | Gesco Intl., Inc. | 1994-07-29 | Traditional | PDF ↗ |
| K940871 | UMBILI-CATH-P | Gesco Intl., Inc. | 1994-04-29 | Traditional | PDF ↗ |
| K921374 | VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER | Vygon Corp. | 1992-10-26 | Traditional | PDF ↗ |
| K921352 | VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH | Vygon Corp. | 1992-10-26 | Traditional | PDF ↗ |
| K911607 | GESCO UMBILI-CATH | Gesco Intl., Inc. | 1991-06-11 | Traditional | PDF ↗ |
| K896041 | GESCO DUAL LUMEN UMBILICATH II-DL | Gesco Intl., Inc. | 1990-04-17 | Traditional | PDF ↗ |
| K890685 | BARD UMBILICAL VESSEL CATHETER | C.R. Bard, Inc. | 1989-02-28 | Traditional | PDF ↗ |
| K850884 | ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER | Sherwood Medical Co. | 1985-10-17 | Traditional | PDF ↗ |
| K851005 | XRO UMBILICAL CATHETER-CODE 270 | Vygon Corp. | 1985-05-21 | Traditional | PDF ↗ |
| K840339 | UMBILICAL VESSEL CATHETER | Catheter Technology Corp. | 1984-07-25 | Traditional | PDF ↗ |
| K831988 | INTRAVASCULAR CATHETER | C.R. Bard, Inc. | 1983-11-08 | Traditional | PDF ↗ |
| K802414 | UMBILI-CATH CATHETER | Int'L Corp. | 1980-10-23 | Traditional | PDF ↗ |
| K771022 | CATHETER, UMBILICAR ARTERY | Axiom Medical, Inc. | 1977-11-29 | Traditional | PDF ↗ |
| K771891 | CATHETER, UMBILICAL, VICRA | Travenol Laboratories, S.A. | 1977-11-02 | Traditional | PDF ↗ |
| K760966 | CATHETER, UMBILICAL ARTERY | Sherwood Medical Industries | 1977-01-26 | Traditional | PDF ↗ |
Product code FOS · Class II · General Hospital. Data: openFDA.