K191195 is an FDA 510(k) clearance for the PiccGuard. This device is classified as a Catheter Access Cover, Tamper-resistant (Class II - Special Controls, product code PZW).
Submitted by Piccguard, LLC (Beloit, US). The FDA issued a Cleared decision on January 3, 2020, 245 days after receiving the submission on May 3, 2019.
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 | K191195 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2019 |
| Decision Date | January 03, 2020 |
| Days to Decision | 245 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 |