The following data is part of a premarket notification filed by Footprint Medical Inc. with the FDA for Footprint Medical Peripherally Inserted Central Catheter.
| Device ID | K093252 |
| 510k Number | K093252 |
| Device Name: | FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| 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 | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-16 |
| Decision Date | 2009-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858778006048 | K093252 | 000 |
| 10858778006031 | K093252 | 000 |
| 10858778006024 | K093252 | 000 |