K041495 is an FDA 510(k) clearance for the PENTADEFLUE IV SOLUTION ADMINISTRATION SETS. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Pentaferte S.P.A (Campli (Teramo), IT). The FDA issued a Cleared decision on April 15, 2005, 315 days after receiving the submission on June 4, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K041495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2004 |
| Decision Date | April 15, 2005 |
| Days to Decision | 315 days |
| Submission Type | Abbreviated |
| 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 |