K040533 is an FDA 510(k) clearance for the 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 September 17, 2004, 200 days after receiving the submission on March 1, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K040533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2004 |
| Decision Date | September 17, 2004 |
| Days to Decision | 200 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 |