The following data is part of a premarket notification filed by Kawasumi Laboratories, Inc. with the FDA for K-shield Advantage Port Access Infusion Set (pais).
| Device ID | K190233 |
| 510k Number | K190233 |
| Device Name: | K-Shield Advantage Port Access Infusion Set (PAIS) |
| Classification | Set, Administration, Intravascular |
| Applicant | Kawasumi Laboratories, Inc. Shinagawa Intercity Tower B, 9th Floor 2-15-2, Konan, Minato-Ku Tokyo, JP 108-6109 |
| Contact | Katsu Furuya |
| Correspondent | Valerie Followell Regulatory Compliance Associates, Inc. 10411 Corporate Drive, Suite 102 Pleasant Prairie, WI 53158 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-06 |
| Decision Date | 2019-05-02 |