FDA product code PZW: Catheter Access Cover, Tamper-Resistant
PZW is the FDA product code for catheter access cover, tamper-resistant. It is a Class II device, regulated under 21 CFR 880.5970 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under PZW, 1 in the last five years, from 2 different applicants. The average 510(k) review took 168 days (median 168).
Definition
A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter
Classification
| Field | Value |
|---|---|
| Device name | Catheter Access Cover, Tamper-Resistant |
| Device class | Class II |
| Regulation | 21 CFR 880.5970 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for PZW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 245 |
| 2022 | 1 | 90 |
Compare with all 510(k) review times · Search every PZW clearance
Top PZW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| 3M Company | 1 | 2022-05-23 |
| Piccguard, LLC | 1 | 2020-01-03 |
Most recent PZW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220507 | 3M Company | 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large | 2022-05-23 | 90 |
| K191195 | Piccguard, LLC | PiccGuard | 2020-01-03 | 245 |
Recalls for PZW devices
openFDA lists no recalls for product code PZW.
Frequently asked questions
What is FDA product code PZW?
PZW is the FDA product code for catheter access cover, tamper-resistant. It is a Class II device, regulated under 21 CFR 880.5970 and reviewed by the General Hospital panel.
What device class is PZW?
Class II, regulation 21 CFR 880.5970. Typical premarket route: 510(k).
How long does a 510(k) take for product code PZW?
Across 2 cleared submissions the average was 168 days from receipt to decision (median 168).
Which companies have the most PZW clearances?
3M Company (1); Piccguard, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PZW
- Run a recall and safety report across every PZW manufacturer
- Watch product code PZW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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