K100720 is an FDA 510(k) clearance for the K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Kawasumi Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on November 18, 2010, 248 days after receiving the submission on March 15, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K100720 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2010 |
| Decision Date | November 18, 2010 |
| Days to Decision | 248 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 |