K051264 is an FDA 510(k) clearance for the COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Unomedical A/S (Roskilde, DK). The FDA issued a Cleared decision on September 1, 2005, 108 days after receiving the submission on May 16, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K051264 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2005 |
| Decision Date | September 01, 2005 |
| Days to Decision | 108 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 |