The following data is part of a premarket notification filed by Footprint Medical with the FDA for Footprint Medical Silicone Umbilical Catheter.
| Device ID | K091214 |
| 510k Number | K091214 |
| Device Name: | FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER |
| Classification | Catheter, Umbilical Artery |
| Applicant | FOOTPRINT MEDICAL 1203 CAMDEN ST. San Antonio, TX 78215 |
| Contact | Clyde Baker |
| Correspondent | Clyde Baker FOOTPRINT MEDICAL 1203 CAMDEN ST. San Antonio, TX 78215 |
| Product Code | FOS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-27 |
| Decision Date | 2009-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858778006345 | K091214 | 000 |
| 10858778006338 | K091214 | 000 |
| 10858778006321 | K091214 | 000 |