K201469 is an FDA 510(k) clearance for the Mini Spike Plus 6/8R. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on December 9, 2020, 189 days after receiving the submission on June 3, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K201469 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2020 |
| Decision Date | December 09, 2020 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHI — Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |