K123344 is an FDA 510(k) clearance for the K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS). This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Kawasumi Laboratories, Inc. (Kenosha, US). The FDA issued a Cleared decision on March 7, 2013, 127 days after receiving the submission on October 31, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K123344 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2012 |
| Decision Date | March 07, 2013 |
| Days to Decision | 127 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 |