K141834 is an FDA 510(k) clearance for the SAPPHIRE ADMINISTRATION SET. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Q Core Medical , Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on August 5, 2014, 29 days after receiving the submission on July 7, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K141834 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2014 |
| Decision Date | August 05, 2014 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |