K220507 is an FDA 510(k) clearance for the 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large. This device is classified as a Catheter Access Cover, Tamper-resistant (Class II - Special Controls, product code PZW).
Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on May 23, 2022, 90 days after receiving the submission on February 22, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970. A Tamper Resistant Catheter Access Cover Is Intended To Control Unauthorized Access To A Central Venous Catheter.
| 510(k) Number | K220507 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2022 |
| Decision Date | May 23, 2022 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PZW - Catheter Access Cover, Tamper-resistant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |
| Definition | A Tamper Resistant Catheter Access Cover Is Intended To Control Unauthorized Access To A Central Venous Catheter |