The following data is part of a premarket notification filed by Tz Medical Inc with the FDA for Arc Adjustable Radial Cuff Compression Device.
| Device ID | K173563 |
| 510k Number | K173563 |
| Device Name: | ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE |
| Classification | Clamp, Vascular |
| Applicant | TZ Medical Inc 17750 SW Upper Boones Ferry Rd #150 Portland, OR 97224 |
| Contact | John Lubisich |
| Correspondent | John Lubisich TZ Medical Inc 17750 SW Upper Boones Ferry Rd #150 Portland, OR 97224 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-17 |
| Decision Date | 2018-01-10 |
| Summary: | summary |