K191362 is an FDA 510(k) clearance for the LifeFlow Blood System. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by 410 Medical, Inc. (Durham, US). The FDA issued a Cleared decision on May 20, 2020, 364 days after receiving the submission on May 22, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K191362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2019 |
| Decision Date | May 20, 2020 |
| Days to Decision | 364 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA - Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |