K071846 is an FDA 510(k) clearance for the MODIFICATION TO EZ HUBER SAFETY INFUSION SET. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Pfm Medical, Inc. (Oceanside, US). The FDA issued a Cleared decision on August 30, 2007, 56 days after receiving the submission on July 5, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K071846 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2007 |
| Decision Date | August 30, 2007 |
| Days to Decision | 56 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 |