The following data is part of a premarket notification filed by Linear Health Sciences, Llc with the FDA for Orchid Safety Release Valve(tm).
| Device ID | K212064 |
| 510k Number | K212064 |
| Device Name: | Orchid Safety Release Valve(TM) |
| Classification | Intravenous Catheter Force-activated Separation Device. |
| Applicant | Linear Health Sciences, LLC 5333 Wisteria Drive Oklahoma City, OK 73142 |
| Contact | Daniel Clark |
| Correspondent | Jessica Czamanski RQM+ 2790 Mosside Blvd #800 Monroeville, PA 15146 |
| Product Code | QOI |
| CFR Regulation Number | 880.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-02 |
| Decision Date | 2022-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10869184000308 | K212064 | 000 |