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 | K213531 |
| 510k Number | K213531 |
| 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 | 2021-11-05 |
| Decision Date | 2021-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00389701012476 | K213531 | 000 |
| 00389701012469 | K213531 | 000 |