The following data is part of a premarket notification filed by 410 Medical Innovation, Llc with the FDA for Lifeflow Rapid Infusion Device (lifeflow Device).
| Device ID | K153731 |
| 510k Number | K153731 |
| Device Name: | LifeFlow Rapid Infusion Device (LifeFlow Device) |
| Classification | Set, Administration, Intravascular |
| Applicant | 410 Medical Innovation, LLC 201 West Main Street, Suite 305 Durham, NC 27701 |
| Contact | Galen Robertson |
| Correspondent | Dawn Reilly-o'dell Full Circle Regulatory Consulting, LLC 201 West Main Street, Suite 305 Durham, NC 27701 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-28 |
| Decision Date | 2016-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000288606 | K153731 | 000 |
| B355FG50011 | K153731 | 000 |