FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER
FDA 510(k) clearance K091214 · decided 2009-09-25
Clearance details
- K-number
- K091214
- Device name
- FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER
- Applicant
- Footprint Medical
- Decision
- Substantially Equivalent
- Date received
- 2009-04-27
- Decision date
- 2009-09-25
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- FOS
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Umbilical Vessels Catheter (K201697) | Haolang Medical USA Corporation | 2021-05-06 |
| MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. (K130725) | Covidien Lp, Formerly Registered AS Kendall | 2013-04-17 |
| FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER (K120304) | Footprint Medical, Inc. | 2012-03-01 |
| FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN (K091213) | Footprint Medical | 2009-09-25 |
| NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 (K081515) | Neomed, Inc. | 2008-07-21 |
| NEOMED SINGLE LUMEN UMBILICAL CATHETER (K073596) | Neomed, Inc. | 2008-02-22 |
| VYGON DOUBLE LUMEN UMBILICAL CATHETER (K981630) | Schiff & Co. | 1998-10-01 |
| NEO-CARE DUAL LUMEN UMBILICAL CATHETER (K963972) | Klein-Baker Medical, Inc. | 1996-12-24 |
| ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY (K954300) | Sherwood Medical Co. | 1995-12-13 |
| ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER (K951738) | Sherwood Medical Co. | 1995-09-29 |
| ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAY (K951737) | Sherwood Medical Co. | 1995-09-28 |
| CENTURION UMBILICAL CATHETER (K942353) | Tri-State Hospital Supply Corp. | 1995-08-15 |
Recalls involving this device
No recalls on record reference this clearance.