The following data is part of a premarket notification filed by Navilyst Medical, Inc. with the FDA for Bioflo Midline Catheter.
| Device ID | K150407 |
| 510k Number | K150407 |
| Device Name: | BioFlo Midline Catheter |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Contact | Brandon M Brackett |
| Correspondent | Brandon M Brackett NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-18 |
| Decision Date | 2015-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H965468100 | K150407 | 000 |
| H965460610 | K150407 | 000 |
| H965460510 | K150407 | 000 |
| H965460181 | K150407 | 000 |
| H965460151 | K150407 | 000 |
| H965460140 | K150407 | 000 |
| H965460130 | K150407 | 000 |
| H965460120 | K150407 | 000 |
| H965464801 | K150407 | 000 |
| H965464701 | K150407 | 000 |
| H965460171 | K150407 | 000 |
| H965460710 | K150407 | 000 |
| H965460810 | K150407 | 000 |
| H965467100 | K150407 | 000 |
| H965466100 | K150407 | 000 |
| H965465100 | K150407 | 000 |
| H965464901 | K150407 | 000 |
| H965464601 | K150407 | 000 |
| H965464100 | K150407 | 000 |
| H965463100 | K150407 | 000 |
| H965462100 | K150407 | 000 |
| H965461900 | K150407 | 000 |
| H965460910 | K150407 | 000 |
| H965460161 | K150407 | 000 |