K060580 is an FDA 510(k) clearance for the K-SHIELD PORT ACCESS INFUSION SET. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Kawasumi Laboratories, Inc. (Tampa, US). The FDA issued a Cleared decision on June 6, 2006, 92 days after receiving the submission on March 6, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K060580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2006 |
| Decision Date | June 06, 2006 |
| Days to Decision | 92 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 |