The following data is part of a premarket notification filed by Footprint Medical Inc. with the FDA for Footprint Medical Polyurethane Umbilical Catheter.
| Device ID | K120304 |
| 510k Number | K120304 |
| Device Name: | FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER |
| Classification | Catheter, Umbilical Artery |
| Applicant | FOOTPRINT MEDICAL INC. 1203 CAMDEN STREET San Antonio, TX 78215 |
| Contact | Clyde Baker |
| Correspondent | Clyde Baker FOOTPRINT MEDICAL INC. 1203 CAMDEN STREET San Antonio, TX 78215 |
| Product Code | FOS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-01 |
| Decision Date | 2012-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858778006543 | K120304 | 000 |
| 10858778006536 | K120304 | 000 |
| 10858778006406 | K120304 | 000 |
| 10858778006390 | K120304 | 000 |
| 10858778006383 | K120304 | 000 |
| 10858778006376 | K120304 | 000 |