The following data is part of a premarket notification filed by Twin Star Medical, Inc. with the FDA for Twin Star Compartment Syndrome Pressure Monitoring And Fluid Collection Catheter System.
| Device ID | K041771 |
| 510k Number | K041771 |
| Device Name: | TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM |
| Classification | Monitor, Pressure, Intracompartmental |
| Applicant | TWIN STAR MEDICAL, INC. 555 13TH STREET NW Washington, DC 20004 |
| Contact | Jonathan Kahan |
| Correspondent | Jonathan Kahan TWIN STAR MEDICAL, INC. 555 13TH STREET NW Washington, DC 20004 |
| Product Code | LXC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-30 |
| Decision Date | 2004-09-14 |
| Summary: | summary |