510(k) K220507
- Device
- 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large
- Applicant
- 3M Company
- 510(k) number
- K220507
- Product code
- PZW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-05-23
- Date received
- 2022-02-22
- Regulation
- 880.5970
- Classification name
- Catheter Access Cover, Tamper-Resistant
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Hilary Hovde
- Address
- 2510 Conway Ave., Bldg. 275-5w-06 St. Paul MN US 55144 55144
FDA Registration Numbers
- 3016472589
- 3003589911
Source Documents
Other 510(k) Records For Product Code PZW
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191195 | PiccGuard | Piccguard, LLC | 2020-01-03 |