The following data is part of a premarket notification filed by Medsource Labs with the FDA for Medsource Cathmed Iv Catheter.
| Device ID | K193278 |
| 510k Number | K193278 |
| Device Name: | MedSource CathMED IV Catheter |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MedSource Labs 4201 Norex Drive Chaska, MN 55318 |
| Contact | Emilie Andrews |
| Correspondent | Emilie Andrews MedSource Labs 4201 Norex Drive Chaska, MN 55318 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-27 |
| Decision Date | 2020-08-07 |