K050906 is an FDA 510(k) clearance for the VITALCARE I.V. ADMINISTRATION SET. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Vitalcare Group, Inc. (Miami, US). The FDA issued a Cleared decision on August 23, 2005, 134 days after receiving the submission on April 11, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K050906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2005 |
| Decision Date | August 23, 2005 |
| Days to Decision | 134 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 |