K103562 is an FDA 510(k) clearance for the CENTURION PRESSURE INJECTABLE EXTENSION SET. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Centurion Medical Products Corporation (Williamston, US). The FDA issued a Cleared decision on June 23, 2011, 199 days after receiving the submission on December 6, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K103562 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2010 |
| Decision Date | June 23, 2011 |
| Days to Decision | 199 days |
| Submission Type | Abbreviated |
| 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 |