K151250 is an FDA 510(k) clearance for the Smart Set. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Top Spins, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on June 7, 2016, 392 days after receiving the submission on May 12, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K151250 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2015 |
| Decision Date | June 07, 2016 |
| Days to Decision | 392 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |