The following data is part of a premarket notification filed by Navarre Biomedical Ltd. with the FDA for Navarre N-fuser(tm) Peripheral Infusion Catheter.
| Device ID | K945909 |
| 510k Number | K945909 |
| Device Name: | NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | NAVARRE BIOMEDICAL LTD. 2545 FERNBROOK LN. NORTH Plymouth, MN 55447 |
| Contact | Gregg S Sutton |
| Correspondent | Gregg S Sutton NAVARRE BIOMEDICAL LTD. 2545 FERNBROOK LN. NORTH Plymouth, MN 55447 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-02 |
| Decision Date | 1995-06-02 |