The following data is part of a premarket notification filed by Innovative Trauma Care Inc with the FDA for Itclamp50.
| Device ID | K150813 |
| 510k Number | K150813 |
| Device Name: | ITClamp50 |
| Classification | Clamp, Vascular |
| Applicant | INNOVATIVE TRAUMA CARE INC 3463 MAGIC DR. SUITE 120 San Antonio, TX 78229 |
| Contact | Ian Atkinson |
| Correspondent | Ian Atkinson 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-27 |
| Decision Date | 2015-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10854874004032 | K150813 | 000 |
| 20854874004015 | K150813 | 000 |
| 20854874004008 | K150813 | 000 |