Arc Adjustable Radial Cuff Compression Device
FDA 510(k) clearance K252772 · decided 2026-05-22
Clearance details
- K-number
- K252772
- Device name
- Arc Adjustable Radial Cuff Compression Device
- Applicant
- Tz Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-02
- Decision date
- 2026-05-22
- Days to decision
- 262 days
- Clearance type
- Traditional
- Product code
- DXC
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tualatin, OR, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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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 |