The following data is part of a premarket notification filed by Innovative Trauma Care Inc with the FDA for Itclamp 50.
| Device ID | K123551 |
| 510k Number | K123551 |
| Device Name: | ITCLAMP 50 |
| Classification | Clamp, Vascular |
| Applicant | INNOVATIVE TRAUMA CARE INC 3463 MAGIC DR. SUITE 120 San Antonio, TX 78229 |
| Contact | Richard Waite |
| Correspondent | Richard Waite INNOVATIVE TRAUMA CARE INC 3463 MAGIC DR. SUITE 120 San Antonio, TX 78229 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-19 |
| Decision Date | 2013-05-14 |
| Summary: | summary |