The following data is part of a premarket notification filed by Footprint Medical with the FDA for Footprint Urinary Drainage Catheter.
| Device ID | K090576 |
| 510k Number | K090576 |
| Device Name: | FOOTPRINT URINARY DRAINAGE CATHETER |
| Classification | Catheter, Straight |
| 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 | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-03 |
| Decision Date | 2009-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858778006482 | K090576 | 000 |
| 10858778006475 | K090576 | 000 |
| 10858778006468 | K090576 | 000 |
| 10858778006451 | K090576 | 000 |
| 10858778006444 | K090576 | 000 |
| 10858778006437 | K090576 | 000 |
| 10858778006420 | K090576 | 000 |
| 10858778006413 | K090576 | 000 |