ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE
FDA 510(k) clearance K173563 · decided 2018-01-10
Clearance details
- K-number
- K173563
- Device name
- ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE
- Applicant
- Tz Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-11-17
- Decision date
- 2018-01-10
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- DXC
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Tz Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors (P200005) | Tz Medical, Inc. | 2024-01-09 |