The following data is part of a premarket notification filed by Terumo Medical Corporation with the FDA for Tr Band Radial Compression Device.
| Device ID | K152525 |
| 510k Number | K152525 |
| Device Name: | TR BAND Radial Compression Device |
| Classification | Clamp, Vascular |
| Applicant | TERUMO MEDICAL CORPORATION 950 ELKTON BLVD Elkton, MD 21921 |
| Contact | Liang Lu |
| Correspondent | Liang Lu TERUMO MEDICAL CORPORATION 950 ELKTON BLVD Elkton, MD 21921 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-03 |
| Decision Date | 2015-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50389701011351 | K152525 | 000 |
| 50389701011344 | K152525 | 000 |