The following data is part of a premarket notification filed by Piccguard Llc with the FDA for Piccguard.
| Device ID | K191195 |
| 510k Number | K191195 |
| Device Name: | PiccGuard |
| Classification | Catheter Access Cover, Tamper-resistant |
| Applicant | PiccGuard LLC 2677 Sarah Lane Beloit, WI 53511 |
| Contact | Katie Justus |
| Correspondent | E.j. Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | PZW |
| Subsequent Product Code | FPA |
| Subsequent Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-03 |
| Decision Date | 2020-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B38320517205181 | K191195 | 000 |
| B38320517205182 | K191195 | 000 |