510(k) K191195
K191195 is an FDA 510(k) premarket notification submitted by Piccguard, LLC for the device "PiccGuard". The FDA issued a decision of Substantially Equivalent on January 3, 2020. The device falls under product code PZW (Catheter Access Cover, Tamper-Resistant), a Class II device regulated under 21 CFR 880.5970.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 2020
- Date Received
- May 3, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter Access Cover, Tamper-Resistant
- Device Class
- Class II
- Regulation Number
- 880.5970
- Review Panel
- HO
- Submission Type
A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter