The following data is part of a premarket notification filed by Medix, Inc. with the FDA for Protectiv Jelco Safety I.v. Catheter, Model 3600 Series.
| Device ID | K041345 |
| 510k Number | K041345 |
| Device Name: | PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MEDIX, INC. 6250 SHIER RINGS ROAD Dublin, OH 43016 |
| Contact | Barbara Law |
| Correspondent | Barbara Law MEDIX, INC. 6250 SHIER RINGS ROAD Dublin, OH 43016 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-20 |
| Decision Date | 2004-07-22 |