The following data is part of a premarket notification filed by Icu Medical with the FDA for Swabtip Male Disinfectant Cap.
| Device ID | K190918 |
| 510k Number | K190918 |
| Device Name: | SwabTip Male Disinfectant Cap |
| Classification | Cap, Device Disinfectant |
| Applicant | ICU Medical 600 N. Field Drive Lake Forest, IL 60045 |
| Contact | Nichelle Cato |
| Correspondent | Nichelle Cato ICU Medical 600 N. Field Drive Lake Forest, IL 60045 |
| Product Code | QBP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-09 |
| Decision Date | 2020-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30887709097828 | K190918 | 000 |