K950153 is an FDA 510(k) clearance for the VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Imed Corp. (San Diego, US). The FDA issued a Cleared decision on August 24, 1995, 219 days after receiving the submission on January 17, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K950153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 1995 |
| Decision Date | August 24, 1995 |
| Days to Decision | 219 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 |