The following data is part of a premarket notification filed by Navilyst Medical, Inc. with the FDA for Bioflo Midline Catheter.
| Device ID | K161866 |
| 510k Number | K161866 |
| Device Name: | BioFlo Midline Catheter |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 07152 |
| Contact | Robin Fuller |
| Correspondent | Robin Fuller NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 07152 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-07 |
| Decision Date | 2016-09-08 |
| Summary: | summary |