510(k) K220507
K220507 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large". The FDA issued a decision of Substantially Equivalent on May 23, 2022. The device falls under product code PZW (Catheter Access Cover, Tamper-Resistant), a Class II device regulated under 21 CFR 880.5970. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2022
- Date Received
- February 22, 2022
- 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