K030385 is an FDA 510(k) clearance for the IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Kawasumi Laboratories America, Inc. (Tampa, US). The FDA issued a Cleared decision on April 15, 2003, 69 days after receiving the submission on February 5, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K030385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2003 |
| Decision Date | April 15, 2003 |
| Days to Decision | 69 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 |