The following data is part of a premarket notification filed by Footprint Medical Inc. with the FDA for Footprint Medical Polyurethane Picc Catheter.
| Device ID | K130507 |
| 510k Number | K130507 |
| Device Name: | FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | FOOTPRINT MEDICAL INC. 12727 CIMARRON PATH San Antonio, TX 78249 |
| Contact | Clyde N Baker |
| Correspondent | Clyde N Baker FOOTPRINT MEDICAL INC. 12727 CIMARRON PATH San Antonio, TX 78249 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-27 |
| Decision Date | 2013-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858778006109 | K130507 | 000 |
| 10858778006093 | K130507 | 000 |
| 10858778006086 | K130507 | 000 |
| 10858778006079 | K130507 | 000 |
| 10858778006062 | K130507 | 000 |
| 10858778006055 | K130507 | 000 |
| 00858778006881 | K130507 | 000 |
| 00858778006874 | K130507 | 000 |
| 00858778006867 | K130507 | 000 |