The following data is part of a premarket notification filed by Footprint Medical with the FDA for Footprint Medical 1.9 Fr Picc Introducer.
| Device ID | K093026 |
| 510k Number | K093026 |
| Device Name: | FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-29 |
| Decision Date | 2010-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858778006017 | K093026 | 000 |
| 10858778006000 | K093026 | 000 |