3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large
FDA 510(k) K220507 · 3M Company
510(k) numberK220507
Submission
- Device name
- 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large
- Applicant
- 3M Company
St. Paul, MN, US - Received
- February 22, 2022
- Decision date
- May 23, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PZW – Catheter Access Cover, Tamper-Resistant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5970
- Specialty
- General Hospital
A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter
Other 510(k)s with product code PZW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K191195 | PiccGuardPZW · Traditional | Piccguard, LLC | 01/03/2020SE |
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Questions and answers
When was 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large cleared by the FDA?
3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large (K220507) received a 510(k) decision of Substantially Equivalent on May 23, 2022, 90 days after the submission was received.
What is the product code of K220507?
The FDA product code is PZW – Catheter Access Cover, Tamper-Resistant, a Class II (moderate risk) device regulated under 21 CFR 880.5970.